Learning Outcomes: 1. Navigate genomic databases to find required information and data
Audience: Undergraduate

2. Interpret results using available bioinformatic tools
Audience: Undergraduate

3. Formulate a research question and testable hypothesis
Audience: Undergraduate

4. Refute or support a hypothesis using evidence
Audience: Undergraduate

5. Interpret data and draw conclusions
Audience: Undergraduate

6. Communicate research design and results in written and oral forms
Audience: Undergraduate

Learning Outcomes: 1. Define basic principles of pharmacology including pharmacokinetics and pharmacodynamics
Audience: Undergraduate

2. Memorize examples of drugs, drug classes, and pharmacology of drugs used to treat various disease states including anxiety, depression, pain, schizophrenia, Alzheimer’s disease, cancer, and infectious diseases
Audience: Undergraduate

3. Describe examples of drugs, drug classes, and pharmacology of drugs used for non-medical purposes including alcohol, caffeine, nicotine, barbiturates, amphetamine, marijuana, cocaine, and opiates
Audience: Undergraduate

4. Describe examples of drugs, drug classes, and pharmacology of drugs used as PEDs including anabolic steroids and blood doping drugs
Audience: Undergraduate

Learning Outcomes: 1. State the major physical and chemical properties of drugs and excipients that influence the performance of drugs and dosage forms.
Audience: Graduate

2. Apply the different expressions for the concentrations and doses of drug products, and convert different expressions for concentrations and doses.
Audience: Graduate

3. Apply thermodynamic principles to important equilibria in pharmaceutical systems, including isotonicity, acid-base equilibrium, binding equilibrium, partition, hygroscopicity, and solubility.
Audience: Graduate

4. Propose procedures to prepare isotonic solutions and buffered solutions.
Audience: Graduate

5. Understand suspensions and colloids and their role in drug formulations
Audience: Graduate

6. Calculate the distribution of drugs between aqueous and lipid phases based on the principle of partition.
Audience: Graduate

7. Identify the different solid phases of the same drug and predict their impact on drug performance.
Audience: Graduate

8. Predict the aqueous solubility of drugs and its dependence on pH, common ions, and solid forms, and understand its impact on drug performance.
Audience: Graduate

9. Predict shelf life and suggest storage conditions from reaction rate constants and orders of reactions.
Audience: Graduate

10. State the major factors that influence the chemical stability of drugs (e.g., temperature, humidity, light, pH, oxygen, and free radicals) and the common reaction mechanisms (e.g., hydrolysis and oxidation), and propose approaches to stabilization and extending the expiration date of drug products (e.g., pH control, antioxidants, and packaging).
Audience: Graduate

Learning Outcomes: 1. Deduce aspects of protein structure and catalysis from kinetics and other data
Audience: Graduate

2. Summarize how nucleic acids are used to store information in living organisms, including the molecular mechanisms for replication and protein expression
Audience: Graduate

3. Apply knowledge of the pathways by which energy is derived from fats and carbohydrates to both the clinical progression of diabetes and its treatment
Audience: Graduate

4. Differentiate between the different methods of biosignaling, in terms of whether energy is required and whether molecules are physically moved through membrane barriers
Audience: Graduate

5. Integrate understanding of biochemical systems and the ways that drugs are able to target them to therapeutic effect
Audience: Graduate

Learning Outcomes: 1. Explain principles of pharmacology
Audience: Undergraduate

2. Apply chemistry and biology knowledge to pharmacokinetics and pharmacodynamics
Audience: Undergraduate

3. Identify types of drugs used to treat various disease states
Audience: Undergraduate

Learning Outcomes: 1. Describe the neurotransmitters of the central and autonomic nervous systems including their physiologic role, distribution, location, synthesis, storage, release, receptor activation and transmitter inactivation which may serve as sites for drug action
Audience: Undergraduate

2. Describe and differentiate the drug pharmacology of drugs that act in the central and autonomic nervous systems
Audience: Undergraduate

Learning Outcomes: 1. Recall the names of different drugs, and be able to link these drug names to not only specific uses, but also to more general concepts about physiology, disease, and drug mechanism of action
Audience: Undergraduate

2. Describe and differentiate the pharmacology of drugs that act on organ systems, including the endocrine, gastrointestinal, cardiovascular, renal, hematopoietic, and immune systems
Audience: Undergraduate

Learning Outcomes: 1. Identify drugs, their therapeutic use, and side effects based on drug name and structure
Audience: Undergraduate

2. Use pharmacophoric drug models to predict potency, metabolism, or side effects
Audience: Undergraduate

3. Apply mechanisms of drug/xenobiotic biotransformation to parent drugs
Audience: Undergraduate

4. Explain factors affecting drug/xenobiotic metabolism in humans, including both environmental and genetic effects and the resulting clinical implications
Audience: Undergraduate

Learning Outcomes: 1. Explain basic chemical principles as they apply to drug SAR
Audience: Undergraduate

2. Identify drug classes and origin based in part on drug structures
Audience: Undergraduate

3. Recognize the mechanism of drugs that act via enzyme inhibition
Audience: Undergraduate

4. Explain the difficulty of drug design in light of side effects and complexity of possible drug targets
Audience: Undergraduate

5. Apply the knowledge of structural modifications to enhance drug delivery via increased solubility, metabolic stability and bioavailability
Audience: Undergraduate

Learning Outcomes: 1. Describe theories, approaches, concepts, and current research findings in the area of drug delivery.
Audience: Graduate

2. Apply knowledge of drug development, dissolution, and dosage forms to delivery systems.
Audience: Graduate

3. Identify the characteristics of various common dosage forms and describe/recognize/explain how composition impacts drug release, stability, and bioavailability.
Audience: Graduate

4. Demonstrate, using knowledge of mathematics, chemistry, and biology, concepts of solubility, stability, drug release, dissolution, diffusion, partitioning, dose, absorption, and disposition as related to pharmacology and pharmacokinetics.
Audience: Graduate

5. Demonstrate underlying principles of advanced drug delivery systems which are either entering clinical practice or on the advanced stage in clinical trials/development phase.
Audience: Graduate

6. Identify the rationale for therapeutic use, administration route, formulation, and manufacture of common dosage forms.
Audience: Graduate

7. Utilize proper techniques and skills to be able to advise patients and health care professionals on drug storage, handling, and administration, as well as be able to identify factors that influence bioavailability and related safety issues.
Audience: Graduate

8. Demonstrate professional and ethical responsibility.
Audience: Graduate

Learning Outcomes: 1. Read and accurately interpret prescription and medication orders
Audience: Undergraduate

2. Correctly identify, interpret and utilize for calculation, the information presented in a written problem, a prescription or medication order, and directions taken from the labeling of a container
Audience: Undergraduate

3. Accurately calculate the quantities needed to compound a dosage form, the dosage of ingredients, and the amount of any drug source required to fulfill the dosing needs of the patient
Audience: Undergraduate

4. Know the dimensions or units of measurements for drugs and chemicals, expressions of quantity and concentration for drug products and preparations, and appropriate methods of expressing doses and dosing regimens for patients
Audience: Undergraduate

5. Perform the accepted techniques used for extemporaneous compounding of non-sterile drug products
Audience: Undergraduate

6. Identify the physical and chemical properties of drugs, pharmaceutical necessities, excipients, and dosage forms, and practice with handling and manipulating them
Audience: Undergraduate

7. Use a variety of pharmacy references for determining appropriate doses and dosage regimens, and drug delivery systems
Audience: Undergraduate

Learning Outcomes: 1. Become proficient in solving mathematical problems for determining appropriate dosing of medications, for compounding prescription orders, and for providing safe and accurate drug therapy for patients
Audience: Undergraduate

2. Improve compounding skills and ability to critically analyze prescription and medication orders for compounded drug preparations
Audience: Undergraduate

3. Develop competence in aseptic processing and in dealing with intravenous solutions, IV admixtures, reconstitution of parenterals and total parenteral nutrition solutions
Audience: Undergraduate

4. Utilize pharmacy reference books to determine which references to use for specific problems or questions
Audience: Undergraduate

5. Illustrate practical aspects of compatibility and stability of compounded prescriptions and parenteral products, including the application of scientific principles, legal standards, and use of published literature in assigning beyond-use dates to drug preparations
Audience: Undergraduate

6. Explain the pharmacists' responsibility for handling and dispensing quality pharmaceutical drug products and preparations as promulgated in the USP
Audience: Undergraduate

Learning Outcomes: 1. Demonstrate procedural knowledge of general laboratory skills
Audience: Undergraduate

2. Explain the processes and applications related to science subjects
Audience: Undergraduate

3. Handle basic scientific equipment carefully and correctly
Audience: Undergraduate

4. Demonstrate a scientific understanding of molecular biological concepts
Audience: Undergraduate

5. Coherently convey scientific data and results in a written report
Audience: Undergraduate

6. Define principles of evidence-based date interpretation and scientific integrity
Audience: Undergraduate

Learning Outcomes: 1. Outline the key theoretical issues in history of medicine and drugs.
Audience: Graduate

2. Explain the relationship, including explanatory models of change, between specific medicines and drugs and society.
Audience: Graduate

3. Critically assess the historiographies of the history of medicine.
Audience: Graduate

4. Evaluate the reputations of specific medicines, medicinal substances and drugs.
Audience: Graduate

5. Effectively communicate conclusions regarding the history of medicines and drugs.
Audience: Graduate

6. Apply historical understandings to contemporary issues regarding drug regulation and political conflicts.
Audience: Graduate

Learning Outcomes: 1. Outline the key theoretical issues in the history and historiographical discussions relevant to psychedelics in biomedicine and society.
Audience: Graduate

2. Describe the role of the psychedelics in treatment settings and as part of indigenous and religious rituals.
Audience: Graduate

3. Analyze and present primary and lay literature; apply knowledge to present problems and situations.
Audience: Graduate

4. Critique and construct tools to help shape new understandings of psychedelic historiography.
Audience: Graduate

Learning Outcomes: 1. Recognize the fundamental principles of drug actions at their target sites (e.g. receptors, enzymes, etc.)
Audience: Undergraduate

2. Recognize the various mechanisms by which drugs can mediate their pharmacological effect.
Audience: Undergraduate

3. Describe how drugs mimic or modify physiological function, including the various actions and clinical uses.
Audience: Undergraduate

4. Describe the major classes of therapeutic drugs that affect the primary systems within the body.
Audience: Undergraduate

5. Choose a relevant experimental system to test experimental hypotheses (e.g. in vitro or in vivo; animal species, etc.)
Audience: Undergraduate

6. Design experiments which are properly controlled and which use appropriate statistical methods of data analysis.
Audience: Undergraduate

Learning Outcomes: 1. Identify and describe the major federal statutes and regulations affecting use of controlled substances
Audience: Graduate

2. Identify potential legal problems in use and handling of controlled substances before they may occur
Audience: Graduate

3. Apply knowledge of the statutes/regulations to various research settings
Audience: Graduate

4. Locate and identify reputable sources of legal information
Audience: Graduate

Learning Outcomes: 1. Classify the physiologic and pathophysiologic features of the human endocrine system and the pancreas
Audience: Undergraduate

2. Connect the drugs/drug classes to the pharmacology of drugs used to manage diseases relating to the functions of the endocrine pancreas
Audience: Undergraduate

3. Classify physiologic and pathophysiologic features of the human thyroid gland
Audience: Undergraduate

4. Connect the drugs/drug classes to the pharmacology of drugs used to manage diseases relating to the functions of the thyroid gland
Audience: Undergraduate

5. Classify the physiologic and pathophysiologic features of endocrine sex hormones and human reproduction
Audience: Undergraduate

6. Connect the drugs/drug classes to the pharmacology of drugs used to manage diseases and/or functions of the human reproductive tract
Audience: Undergraduate

7. Describe the physiologic and pathophysiologic features of Calcium Homeostasis
Audience: Undergraduate

8. Connect the drugs/drug classes to the pharmacology of drugs used to manage diseases relating to imbalances of Calcium Homeostasis
Audience: Undergraduate

Learning Outcomes: 1. Discuss the physiology and pathology of toxicology, understanding the basicfundamentals of toxicology and toxic agents
Audience: Both Grad & Undergrad

2. Demonstrate metabolism and breakdown of toxicants using a given dataset
Audience: Both Grad & Undergrad

3. Recognize various experimental models to obtain scientific results
Audience: Both Grad & Undergrad

4. Implement knowledge to design experiments applicable to one’s own research
Audience: Both Grad & Undergrad

5. Critique an example of toxicology in media and develop a presentation of this example
Audience: Both Grad & Undergrad

6. Explore new areas to assist in career development via journal club
Audience: Graduate

Learning Outcomes: 1. Explain and identify the effects of toxicants on specific organs within the human body
Audience: Both Grad & Undergrad

2. Demonstrate metabolism and reactions of toxicants within organ systems using a given dataset
Audience: Both Grad & Undergrad

3. Classify different means of risk assessment and the conceptual rationale behind these methods
Audience: Both Grad & Undergrad

4. Implement knowledge to design experiments applicable to one's own research
Audience: Both Grad & Undergrad

5. Relate specific organ concepts with conceptual examples from M&ENVTOX 625 to enhance scientific understanding
Audience: Undergraduate

6. Appraise concepts to research to identify future research concepts.
Audience: Graduate

Learning Outcomes: 1. Describe experimental techniques and measurements used to probe changes in neuronal activity and connectivity and identify the major limitations of each method and propose approaches to overcome those limitations
Audience: Graduate

2. Describe experimental techniques and measurements used to probe changes in neuronal activity and connectivity
Audience: Undergraduate

3. Identify the major known classical psychedelic agents in terms of their chemical structure, targets (receptors, cells, brain areas) in the brain, duration of action, and suitability for administration in a clinical setting
Audience: Undergraduate

4. Identify the major known classical psychedelic agents in terms of their chemical structure, targets (receptors, cells, brain areas) in the brain, duration of action, and suitability for administration in a clinical setting and also summarize the signaling pathways underlying cellular actions of psychedelic agents.
Audience: Graduate

5. Demonstrate knowledge of the cell types and brain areas most likely to mediate distinct behavioral effects of psychedelics, and of the experimental support for these hypotheses.
Audience: Undergraduate

6. Demonstrate knowledge of the cell types and brain areas most likely to mediate distinct behavioral effects of psychedelics, and of the experimental support for these hypotheses, and also demonstrate ability to identify gaps in experimental support for these hypotheses and to design experiments to fill those gaps
Audience: Graduate

7. Identify and summarize the major behavioral assays of the psychedelic experience and of psychiatric disorders (e.g. depression scales).
Audience: Undergraduate

8. Identify and summarize the major behavioral assays of the psychedelic experience and of psychiatric disorders (e.g. depression scales), and also identify and summarize the shortcomings of the major behavioral assays of the psychedelic experience and of psychiatric disorders (e.g. depression scales), and demonstrate ability to propose revisions of those scales to address those shortcomings.
Audience: Graduate

9. Identify and summarize clinical applications of psychedelics, and the theories and factors contributing to their therapeutic benefit
Audience: Undergraduate

10. Identify and summarize clinical applications of psychedelics, and the theories and factors contributing to their therapeutic benefit, and also demonstrate knowledge of the experimental support for each theory and factor.
Audience: Graduate

Learning Outcomes: 1. Explain the biological and pharmacological basis of substance dependence and the mechanisms of commonly abused drugs, including opioids, cannabinoids, psychedelics, amphetamines, and related agents
Audience: Graduate

2. Differentiate between substance use, misuse, abuse, and dependence, and analyze their public health implications
Audience: Graduate

3. Apply best practices for prescribing opioids for acute and chronic pain, including initiation, titration, tapering, and opioid-sparing strategies
Audience: Graduate

4. Develop evidence-based treatment strategies for opioid use disorder and withdrawal management
Audience: Graduate

5. Interpret urine drug tests and Prescription Drug Monitoring Program data to inform clinical decision-making
Audience: Graduate

6. Identify and manage toxicity and overdose from known and unknown substances of abuse
Audience: Graduate

7. Evaluate patterns of misuse in specific populations (e.g., athletes, students) and apply preventive strategies
Audience: Graduate

Learning Outcomes: 1. Describe the roles of psychedelic compounds in the traditional rituals of indigenous peoples, and the impact of psychedelic tourism upon these native societies and their environment.
Audience: Graduate

2. Describe the history and rationale for the regulation and prohibition of these compounds in the past century.
Audience: Graduate

3. Describe the similarities between efforts to decriminalize cannabis and psychedelics, including pros and cons for each position.
Audience: Graduate

4. Describe the path by which psychedelic drugs may be proposed to the FDA for approval drugs, and rescheduled by the DEA.
Audience: Graduate

5. Identify the basic chemical structures of the most common psychedelic tryptamines and phenethylamines, and their usual pharmacologic targets in the brain.
Audience: Graduate

6. Describe and critique examples of the research literature on the human use of psilocybin and LSD for the treatment of diseases such as depression and substance abuse disorders, including proposed metrics of effect.
Audience: Graduate

7. Describe the usual screening, preparation, and care of a subject receiving psilocybin, and the expected skills, training, and role of the attending clinicians.
Audience: Graduate

8. Describe the relationship of psychedelic treatment to other methods of care such as meditation, mindfulness, and cognitive behavioral therapy.
Audience: Graduate

Learning Outcomes: 1. Demonstrate knowledge in a diverse range of drug discovery areas, both from academic and industry settings
Audience: Both Grad & Undergrad

2. Identify mechanisms of action for major drug targets, with emphasis on receptor proteins that constitute targets for a majority of FDA-approved drugs
Audience: Both Grad & Undergrad

3. Explain model systems and methods used for discovery of novel drug targets
Audience: Both Grad & Undergrad

4. Demonstrate knowledge of the basic principles of drug formulation and delivery
Audience: Both Grad & Undergrad

5. Demonstrate knowledge of the current research in drug delivery
Audience: Both Grad & Undergrad

6. Apply knowledge to solve related problems in drug discovery
Audience: Graduate

Learning Outcomes: 1. Describe the role of the endocannabinoid system in human disease.
Audience: Graduate

2. Identify appropriate cannabinoid use in various disease states.
Audience: Graduate

3. Describe the mechanism of action of THC and CBD on several body systems and disease states.
Audience: Graduate

4. Explain the pharmacology of THC and CBD.
Audience: Graduate

5. Describe common / serious drug interactions and adverse effects of cannabis therapies and methods for preventing or minimizing their occurrence.
Audience: Graduate

6. Analyze and present primary and lay literature regarding cannabinoid therapy.
Audience: Graduate

Learning Outcomes: 1. Design and give a verbal scientific presentation that explains the scientific method as it applies to a real-life research project
Audience: Undergraduate

2. Identify and appraise strengths and weaknesses of scientific presentations
Audience: Undergraduate

Learning Outcomes: 1. Execute a hypothesis-driven research or scholarly project that integrates foundational and advanced concepts in pharmaceutical sciences
Audience: Undergraduate

2. Analyze and interpret experimental or computational data using appropriate scientific methodologies, tools, and ethical practices
Audience: Undergraduate

3. Communicate scientific findings effectively through written, oral, or visual formats tailored to academic, professional, or public audiences
Audience: Undergraduate

Learning Outcomes: 1. Summarize scientific logic and planned experiments through an abstract, narrative, and specific aims page
Audience: Graduate

2. Articulate background, significance, and innovation of proposed work
Audience: Graduate

3. Outline methodologies to address a specific set of research questions that include proper controls and analysis methods
Audience: Graduate

4. Describe the NIH grant review process
Audience: Graduate

5. Assess the scientific merit of a grant through preparing written and verbal feedback of peer proposals
Audience: Graduate

Learning Outcomes: 1. Identify, access, and utilize program, campus, and professional resources to further academic and career-related goals.
Audience: Graduate

2. Generate effective job application materials and demonstrate interpersonal and scientific communication skills needed for academic and professional success.
Audience: Graduate

3. Classify common team dynamics and develop personal strategies for collaborating productively in academic and professional teams.
Audience: Graduate

4. Identify situational factors that impact academic and scientific integrity and develop personal strategies for maintaining integrity.
Audience: Graduate

Learning Outcomes: 1. Describe the laws and regulations associated with drugs, biologics, and medical devices in the United States.
Audience: Graduate

2. Justify the importance of regulatory affairs in Life Sciences.
Audience: Graduate

3. Develop a meeting and communication strategy for interacting with the FDA and submitting appropriate documentation
Audience: Graduate

4. Analyze the regulations that impact drug and biologics development, dietary supplements, medical devices, and diagnostics.
Audience: Graduate

5. Analyze and compare nonclinical and clinical product development.
Audience: Graduate

Learning Outcomes: 1. Describe the laws, processes, and regulations associated with drugs, biologics, and medical devices in the United States.
Audience: Graduate

2. Articulate and apply quality based systems in a GxP regulated environment.
Audience: Graduate

3. Explain and analyze when and how the GxP requirements are applied over the course of the product life cycle.
Audience: Graduate

4. Identify the key factors in GxP facility and equipment design, qualification, and maintenance.
Audience: Graduate

5. Identify the key elements required to operate a compliant control laboratory.
Audience: Graduate

Learning Outcomes: 1. Explain the concepts, principles and language of PM and its impact and role in the pharmaceutical industry.
Audience: Graduate

2. Describe the functions of a Project Manager in general and within the drug development process (pre-clinical and clinical phases).
Audience: Graduate

3. Compare and contrast different frameworks and tools of PM to make informed decisions on tailoring the PM approach to suit the project needs.
Audience: Graduate

4. Develop a project charter, statement-of-work, scope of work, work-breakdown structure, a resource-loaded timeline, and a project plan.
Audience: Graduate

5. Apply the critical path method and earned-value analysis to track progress and forecast outcomes against a project’s plan baseline.
Audience: Graduate

6. Weight proper corrective measures according to earned-value analysis forecast methods, to ensure a project’s outcomes and deliverables.
Audience: Graduate

7. Implement risk identification, mitigation and management strategies during project planning (pre-mortem), life cycle, and project closeout (post-mortem).
Audience: Graduate

8. Consolidate the PM concepts and principles studied during the course by developing a Project Plan as Final Project.
Audience: Graduate

Learning Outcomes: 1. Identify the essential features of a well-constructed life cycle management plan for different types of pharmaceutical products (small molecules, biologics, in vitro diagnostics, and medical devices).
Audience: Graduate

2. Analyze the elements of business development for a novel therapeutic and contrast the differences between a startup effort vs. one from an established company.
Audience: Graduate

3. Describe the key business considerations involved in pharmaceutical product development.
Audience: Graduate

4. Justify strategies for mitigating scientific and business risks.
Audience: Graduate

5. Predict and evaluate how different market forces and business decisions impact supply chains.
Audience: Graduate

6. Explain the role of intellectual property during pharmaceutical product development and post-approval lifecycle.
Audience: Graduate

Learning Outcomes: 1. Practice good laboratory techniques including proper handling of instrumentation, aseptic methods, and record keeping
Audience: Graduate

2. Explain the fundamentals of DNA science and be able to isolate genomic DNA and perform allelic discrimination
Audience: Graduate

3. Describe the fundamentals of chromatography and be able to apply them to small molecule analysis
Audience: Graduate

4. Practice routine cell culture techniques including aseptic methods, passaging cells and performing routine toxicity assays
Audience: Graduate

5. Know the different methods to quantify and visualize protein and be able to quantify and visualize proteins in biological samples
Audience: Graduate

6. Recognize the basic mechanisms of cellular toxicity and be able to measure toxic effects of compounds on cells grown in culture
Audience: Graduate

7. Describe the fundamentals of mass spectrometry and be able to apply these to both small molecules and proteins
Audience: Graduate

Learning Outcomes: 1. Identify relevant software platforms, programming tools, and databases relevant to various drug development tasks.
Audience: Graduate

2. Apply best practices, critical thinking skills, and troubleshooting techniques to data analysis projects.
Audience: Graduate

3. Complete data analysis projects representative of those used in drug target characterization.
Audience: Graduate

4. Analyze large high throughput screening (HTS) datasets to confirm positive hits and identify common issues that arise in these datasets.
Audience: Graduate

5. Perform chemical similarity searches and hits triage by applying industry-standard tools and practices.
Audience: Graduate

6. Conduct physiologically-based pharmacokinetic (PBPK) modeling and simulation projects using industry-standard software packages.
Audience: Graduate

Learning Outcomes: 1. Provide historical context for the modern drug discovery and development process.
Audience: Graduate

2. Describe the high-level goals and activities that take place during discovery, preclinical development, and clinical development and the different functional areas that perform this work.
Audience: Graduate

3. Apply the knowledge learned throughout the course to address specific drug development scenarios.
Audience: Graduate

4. Propose novel strategies to address current drug development challenges.
Audience: Graduate

5. Evaluate scientific literature and regulatory documents to find important information about specific drugs.
Audience: Graduate

Learning Outcomes: 1. Demonstrate critical knowledge and in-depth understanding of principles in pharmaceutical sciences and its application in drug development.
Audience: Graduate

2. Identify important research questions, formulate testable hypotheses, design experiments to test those hypotheses and use appropriate statistical methods for analyzing data.
Audience: Graduate

3. Communicate technical knowledge and research results effectively to a range of audiences.
Audience: Graduate

4. Apply ethical principles in all work in both independent and collaborative settings.
Audience: Graduate

5. Demonstrate comprehension of business principles and the ability to apply them to the pharmaceutical industry.
Audience: Graduate

Learning Outcomes: 1. Know where to search for appropriate primary literature and guidance documents associated with drug discovery and development
Audience: Graduate

2. Critically analyze primary research literature and guidance documents in the field of drug discovery and development and neuroscience
Audience: Graduate

3. Succinctly and accurately communicate the merits and limitations of primary drug discovery and development research publications and guidance documents
Audience: Graduate

Learning Outcomes: 1. Demonstrate critical knowledge and in-depth understanding of principles in pharmaceutical sciences and its application in drug development.
Audience: Graduate

2. Identify important research questions, formulate testable hypotheses, design experiments to test those hypotheses and use appropriate statistical methods for analyzing data.
Audience: Graduate

3. Conduct research that contributes to the student's field of study.
Audience: Graduate

4. Communicate technical knowledge and research results effectively to a range of audiences.
Audience: Graduate

5. Apply ethical principles in all work in both independent and collaborative settings.
Audience: Graduate

6. Demonstrate comprehension of business principles and the ability to apply them to the pharmaceutical industry.
Audience: Graduate

Learning Outcomes: 1. Describe how different dosage forms of drugs are used to deliver drugs to specific organs and sites of action and how drugs are removed from the body.
Audience: Graduate

2. Identify how drugs interact with specific target receptors to produce physiological responses, including desired and undesired effects.
Audience: Graduate

3. Analyze how microbes such as viruses and bacteria evade drug treatment.
Audience: Graduate

4. Specify how drugs are used to affect the cardiovascular system.
Audience: Graduate

5. Specify how drugs are used to treat disorders of the CNS.
Audience: Graduate

6. Explain how “drugable targets” have been used to create new drugs.
Audience: Graduate

Learning Outcomes: 1. Describe the phases of drug development from target discovery to investigational new drug (IND) submission and the different functional areas involved.
Audience: Graduate

2. Explain how target pharmacology and drug safety are assessed using both in vitro and in vivo preclinical models.
Audience: Graduate

3. Explain the chemistry, manufacturing, and controls (CMC) activities that take place during discovery and preclinical development.
Audience: Graduate

4. Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions.
Audience: Graduate

5. Evaluate how preclinical development might differ between small molecule drugs and protein therapeutics.
Audience: Graduate

6. Create a preclinical drug development strategy for a specific drug modality and disease combination.
Audience: Graduate

Learning Outcomes: 1. Describe the phases of drug development from first-in-human (FIH) studies to NDA/BLA submission and the different functional areas involved.
Audience: Graduate

2. Explain the goals, expectations, and objectives for the different phases of clinical development and describe innovative trial design
Audience: Graduate

3. Define a biomarker, a companion diagnostic, and a statistical analysis plan (SAP) and describe the important elements of all three.
Audience: Graduate

4. Explain the chemistry, manufacturing, and controls (CMC) activities that take place during clinical phases of drug development and pre-launch.
Audience: Graduate

5. Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions.
Audience: Graduate

6. Evaluate how clinical trial design and execution might differ between different therapeutic areas and between small molecule drugs and protein therapeutics.
Audience: Graduate

7. Create a clinical development strategy for a specific drug modality and disease combination.
Audience: Graduate

Learning Outcomes: 1. Articulate the current challenges across different drug development programs with a nuanced understanding of how drug modality, disease indication, and health care systems play a role.
Audience: Graduate

2. Analyze historical failures and success stories in drug development and describe what went wrong and what worked well.
Audience: Graduate

3. Assess the impact of emerging technologies such as artificial intelligence and advanced delivery technologies on modern drug development.
Audience: Graduate

Learning Outcomes: 1. Explain and apply the concepts, principles, and applications of the most commonly used biochemical and spectrophotometric assays used in drug development to quantify the activity of molecular targets and their modulators.
Audience: Graduate

2. Recommend specific in vitro target assays based on the molecular target of choice and on the desired data output.
Audience: Graduate

3. Compare and contrast cellular models, their applications and limitations, and propose assays that directly measure on-target activity.
Audience: Graduate

4. Critique the use of various animal models when extrapolating pre-clinical data to clinical development.
Audience: Graduate

5. Synthesize knowledge of biochemical, in vitro, and cellular assays to evaluate the validity, applications, and future developments of New Approach Methods (NAMs), according to the current FDA guidelines for animal use in research.
Audience: Graduate

6. Analyze critically experimental approaches, assays outcomes, and their alignment to experimental hypothesis in drug development projects within the broad areas of infectious diseases, auto-immune diseases, and central nervous system (CNS) disorders.
Audience: Graduate

7. Propose adequate experimental assays to support drug development projects hypotheses, demonstrating the limitations and the actual output of different in vitro, cellular, and animal models' assays.
Audience: Graduate

Learning Outcomes: 1. Describe and differentiate the fundamental principles and concepts related to molecular recognition.
Audience: Graduate

2. Integrate interdisciplinary knowledge to explore and explain molecular recognition and reactions in diverse contexts, including chemistry, biology, and materials science.
Audience: Graduate

3. Formulate a research proposal that identifies a novel question in molecular recognition, articulates a testable hypothesis, and outlines a scientifically sound experimental approach.
Audience: Graduate

Learning Outcomes: 1. Analyze and interpret pharmacokinetic profiles following different routes of drug administration and differing dosing regimens
Audience: Graduate

2. Conduct a noncompartmental pharmacokinetic analysis and interpret resulting pharmacokinetic parameter data in context of fundamental pharmacokinetic principles learned
Audience: Graduate

3. Identify the key features of clinical pharmacology studies and how this data will be used to inform drug labeling
Audience: Graduate

4. Describe the importance of a statistical analysis plan and implement key information that should be included
Audience: Graduate

5. Demonstrate their understanding of pharmacokinetic concepts by application to review, analysis, interpretation and reporting from example clinical study data
Audience: Graduate

6. Utilize industry standard software (e.g. Phoenix, R) to review, analyze and report clinical study data
Audience: Graduate

7. Identify regulatory requirements for reporting pharmacokinetic data
Audience: Graduate

8. Describe population pharmacokinetics and physiologically based pharmacokinetic modeling and demonstrate how these approaches may be used in drug development
Audience: Graduate

Learning Outcomes: 1. Identify CNS active drug classes and origins of cholinergic and glutamatergic drugs based in part on structural aspects of the molecule.
Audience: Graduate

2. List physicochemical properties of drugs, anatomical structures and molecular machinery that influence drug access to and efflux from the CNS.
Audience: Graduate

3. Describe the major neurotransmitters of the central nervous system, including their physiologic role, distribution, synthesis, storage, and release.
Audience: Graduate

4. Recall the principal mechanisms by which receptors affect cellular signaling in the Central Nervous System.
Audience: Graduate

5. Match psychiatric conditions and target symptoms of these conditions with appropriate cholinergic and glutamatergic pharmaceuticals.
Audience: Graduate

6. Describe common / serious adverse effects of cholinergic and glutamatergic pharmaceuticals and methods for preventing or minimizing their occurrence.
Audience: Graduate

Learning Outcomes: 1. Identify GABAergic, adrenergic, dopaminergic, serotonergic, and opioid drug classes and drug origins based in part on structural aspects of the molecule.
Audience: Graduate

2. Compare and contrast the actions of GABAergic, adrenergic, dopaminergic, serotonergic, and opioid pharmaceuticals on chemical and electrical signaling within the Central Nervous System.
Audience: Graduate

3. Recognize the psychiatric conditions and target symptoms of these conditions that are commonly treated with GABAergic, adrenergic, dopaminergic, serotonergic, and opioid pharmaceuticals.
Audience: Graduate

4. Describe common / serious adverse effects of GABAergic, adrenergic, dopaminergic, serotonergic, and opioid pharmaceuticals and methods for preventing or minimizing their occurrence.
Audience: Graduate

5. Match GABAergic, adrenergic, dopaminergic, serotonergic, and opioid pharmaceutical agents to the psychiatric conditions they are commonly used to treat.
Audience: Graduate

6. Assess challenges to development and use of psychoactive pharmaceuticals that are either shared across major neurotransmitter systems or unique to specific classes of drugs.
Audience: Graduate

Learning Outcomes: 1. Identify the molecules in molecular solids, including the active pharmaceutical ingredients
Audience: Graduate

2. Use molecular structures to predict solid-state properties
Audience: Graduate

3. Solve crystal structures and use the information to predict the properties of crystals
Audience: Graduate

4. Describe the elemental steps of crystallization and their distinct kinetics and use the information to control a crystallization process
Audience: Graduate

5. Identify, discover and predict crystal polymorphs and predict the effect of polymorphism on material properties, including dissolution and bioavailability
Audience: Graduate

6. Predict aqueous solubility and its dependence on pH, complexing agents, common ions, and solid forms, and understand its impact on drug performance
Audience: Graduate

7. Prevent crystallization and prepare amorphous solids and glasses and describe areas of applications where amorphous materials outperform crystalline materials
Audience: Graduate

8. Design strategies to stabilize molecular solid materials against physical and chemical changes
Audience: Graduate

Learning Outcomes: 1. Classify polymeric drug delivery systems.
Audience: Graduate

2. Differentiate bioconjugation, complexation and encapsulation.
Audience: Graduate

3. Describe major sterile product requirements.
Audience: Graduate

4. Differentiate major mechanisms of drug release.
Audience: Graduate

5. Relate physicochemical properties to biodistribution, metabolism, and clearance.
Audience: Graduate

6. Predict rates of drug absorption after SC injection.
Audience: Graduate

7. Describe peptide long-acting injectables.
Audience: Graduate

8. Describe antibody-drug conjugates.
Audience: Graduate

Learning Outcomes: 1. Apply Deontological and/or Utilitarian arguments to examine personal moral values and use personal experiences to evaluate positive and negative features of current Psychedelic research, access, and use.
Audience: Graduate

2. Explain how socially responsible scientific practices can be used in scientific and medical research, scientific communication, and intellectual property, and whether these practices address societal goals beyond advancing scientific knowledge.
Audience: Graduate

3. Describe elements of proper scientific conduct, the institutional oversight that regulates scientific conduct, and whether these elements are grounded in optimizing research outcomes or following Bioethics Principles.
Audience: Graduate

4. Identify best practices for clinical research by evaluating the costs and benefits of actions necessary to ensure patient safety, reliable data, and public benefit.
Audience: Graduate

5. Explain the elements of misconduct in scientific literature and publishing. Give examples of how this misconduct causes harm to both scientific reputations and public health.
Audience: Graduate

Learning Outcomes: 1. Evaluate how important research questions are identified, hypotheses are formulated, and experiments are designed to test those hypotheses by attending the research presentations of fellow students and outside invited seminar speakers and will use this knowledge to shape their own research ideas
Audience: Graduate

2. Communicate scientific knowledge and research ideas, methodology, models, and results effectively to a range of audiences by presenting a seminar of their original research (in either 931 or 932) with relevant background information and by incorporating changes to their slide design and/or presentation style as they receive feedback from faculty and students
Audience: Graduate

3. Evaluate how existing principles in pharmaceutical sciences intersect with cutting edge research by asking seminar-specific questions and participating in discussions in civil, constructive ways
Audience: Graduate

Learning Outcomes: 1. Evaluate how important research questions are identified, hypotheses are formulated, and experiments are designed to test those hypotheses by attending the research presentations of fellow students and outside invited seminar speakers and will use this knowledge to shape their own research ideas
Audience: Graduate

2. Communicate scientific knowledge and research ideas, methodology, models, and results effectively to a range of audiences by presenting a seminar of their original research (in either 931 or 932) with relevant background information and by incorporating changes to their slide design and/or presentation style as they receive feedback from faculty and students
Audience: Graduate

3. Evaluate how existing principles in pharmaceutical sciences intersect with cutting edge research by asking seminar-specific questions and participating in discussions in civil, constructive ways
Audience: Graduate