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Development steps of pharmacokinetics: a perspective on bioanalytical methods and bioequivalence
1Clinical Pharmacology Unit, Institute for Pharmacokinetic and Analytical Studies SA, Via Mastri 36, 6853 Ligornetto Switzerland. antonio.marzo@ipas-research.com
Current Clinical Pharmacology
|July 17, 2012
Summary
Pharmacokinetics has evolved alongside analytical bioassay methods, supporting drug development from initial screening to regulatory submissions like New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). Advances in analytical techniques have enhanced pharmacokinetic studies, though challenges in bioequivalence remain.
Area of Science:
- Pharmacokinetics
- Analytical Chemistry
- Drug Development
Background:
- Pharmacokinetics (PK) development is intrinsically linked to advancements in bioanalytical methods.
- Early PK studies relied on less specific radiotracing, while modern approaches utilize highly specific techniques.
Purpose of the Study:
- To outline the historical development of pharmacokinetic analysis.
- To highlight the role of PK in New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) processes.
- To identify current challenges in bioequivalence studies.
Main Methods:
- Review of historical analytical techniques used in pharmacokinetics, including radiotracing, gas chromatography, high-pressure liquid chromatography, and tandem mass spectrometry.
- Analysis of the role of pharmacokinetics in different stages of drug development for large and small pharmaceutical companies.
- Examination of regulatory guidelines and persistent issues in bioequivalence.
Main Results:
- Pharmacokinetics has evolved significantly, driven by improvements in analytical bioassay methods.
- PK is crucial for both novel drug discovery (NDA) and generic drug development (ANDA).
- Specific challenges in bioequivalence, such as endogenous substances and Cmax interpretation, persist despite regulatory guidelines.
Conclusions:
- The evolution of analytical methods has been fundamental to the progress of pharmacokinetics in drug development.
- Pharmacokinetics remains essential for regulatory drug approval pathways (NDA/ANDA).
- Further attention is needed from regulatory bodies to address unresolved issues in bioequivalence studies.
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