Spring 2027

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.

offering recorded1 credits
Recorded instructors · Spring 2027 Ardala Katzfuss

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 map

PHM SCI 759 and (PHM SCI 757 or 762)

PHMSCI 765

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Professors

Spring 2027
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Calendar & sections

Spring 2027

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SectionModeEnrolled / capacityWaitlist
LEC 001Online Only0 / 150

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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.

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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

Grades

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Sources & history

UW–Madison

Catalog & offerings

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Selected offering source records
PHMSCI 765 · Spring 2027

Principles of Assay Development

Recorded 2026-10-14
Raw records
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    "title": "Principles of Assay Development",
    "credits_min": 1,
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Model outputs & technical records
Qwen/Qwen3.8-27B
LLM outputs across runs
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Model & dataset provenance
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