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Tailoring bioanalysis for PK studies supporting drug discovery.
P M Timmerman1, R de Vries, B A Ingelse
1Janssen Research Foundation, Belgium. ptimmerm@janbe.jnj.com
Current Topics in Medicinal Chemistry
|March 20, 2002
Summary
Bioanalytical methods are crucial for early drug discovery, enabling faster evaluation of new chemical entities. This approach improves drug development by increasing early attrition rates and ensuring higher quality candidates.
Area of Science:
- Drug Discovery and Development
- Bioanalytical Chemistry
- Pharmacokinetics
Background:
- Increasing demand for pharmacokinetic expertise in early drug discovery.
- Need for early evaluation of in vivo and in vitro pharmacokinetic parameters for new chemical entities.
- Goal to increase attrition rates early in the pipeline to reduce late-stage failures.
Purpose of the Study:
- To provide an overview of bioanalytical techniques and strategies supporting drug discovery.
- To highlight challenges and pitfalls in applying new bioanalytical methods.
- To discuss the adaptation of analytical strategies for novel experimental designs.
Main Methods:
- Review of bioanalytical techniques and strategies.
- Discussion of adaptations for high-throughput synthesis and novel experimental designs (e.g., cassette dosing).
- Emphasis on advancements in lab automation, chromatography, and LC-MS/MS.
Main Results:
- Bioanalytical laboratories play a critical role in modern drug discovery.
- Technological advancements (automation, LC-MS/MS) enhance speed and confidence.
- Quality standards for method development and validation require titration for optimal speed-quality balance.
Conclusions:
- Early pharmacokinetic evaluation is essential for efficient drug discovery.
- Adaptable bioanalytical strategies are key to handling diverse chemical classes and experimental designs.
- Balancing speed and quality in bioanalysis is crucial, with awareness of potential pitfalls.