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Principles of Assay Development
Principles of Assay Development covers biochemical and spectrophotometric bases for molecular target assays, guiding selection of in vitro and cellular assays for drug development hypotheses.
Summary
What you’ll be able to do
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.
Recommend specific in vitro target assays based on the molecular target of choice and on the desired data output.
Compare and contrast cellular models, their applications and limitations, and propose assays that directly measure on-target activity.
Critique the use of various animal models when extrapolating pre-clinical data to clinical development.
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.
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.
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.
Source: UW Guide
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Prerequisites
Course mapPHM SCI 759 and (PHM SCI 757 or 762)
- PHMSCI 759
- take one
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Professors
Spring 2027Historical instructors & teaching patterns
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| Section | Mode | Enrolled / capacity | Waitlist |
|---|---|---|---|
| LEC 001 | Online Only | 0 / 15 | 0 |
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Student experience
the class
Biochemical and spectrophotometric basis of molecular target assays in drug development. Different types of in vitro and cellular assays - how to choose the best one for the problem at hand. On-target and off-target activity. Uses and limitations of biochemical assays, biomarkers, and animal models. Challenges of translating pre-clinical data into clinical assumptions. Biases on non-quantifiable data. Critical evaluation of case studies and experimental assays on infectious diseases, auto-immune diseases, and CNS disorders. Designing proper assays according to drug development projects hypotheses.
difficulty & workload
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Topics
- Biochemical and spectrophotometric molecular target assays
- Selection of in vitro and cellular assays
- On-target and off-target activity
- Biomarkers and animal models
- Translating pre-clinical data to clinical assumptions
- Assays in infectious, autoimmune, and CNS disorders
- New Approach Methods (NAMs) and FDA guidelines
Skills
- Apply biochemical and spectrophotometric assays to quantify molecular target activity
- Recommend in vitro target assays based on molecular targets and data outputs
- Evaluate cellular models and propose assays for on-target activity
- Critique animal models for translating pre-clinical to clinical data
- Evaluate New Approach Methods (NAMs) against FDA guidelines
- Analyze experimental approaches in infectious, autoimmune, and CNS disease contexts
- Design experimental assays supporting drug development project hypotheses
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Principles of Assay Development
Recorded 2026-10-14Raw records
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Model & dataset provenance
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