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Conference report: Bio-International 2005.
Kamal K Midha1, Vinod P Shah, Gur Jai Pal Singh
1College of Pharmacy and Medicine, University of Saskatchewan, Saskatoon, SK, Canada. midha@pharmalytics.ca
Journal of Pharmaceutical Sciences
|November 10, 2006
Summary
This conference summary discusses bioequivalence (BE) for complex drug products. Recommendations include pharmacokinetic approaches and alternate methods for assessing BE in topical, inhaled, and highly variable drugs.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Regulatory Science
Background:
- The International Pharmaceutical Federation/Board of Pharmaceutical Sciences (FIP/BPS) Bio-International 2005 conference addressed critical bioequivalence (BE) challenges.
- Complex drug formulations like topical, inhaled, and highly variable drug products (HVDP) present unique BE assessment hurdles.
Purpose of the Study:
- To summarize discussions and recommendations from the Bio-International 2005 conference on bioequivalence.
- To highlight alternative strategies for assessing BE in challenging drug product categories.
Main Methods:
- The conference involved expert discussions on various BE-related topics.
- Review of pharmacokinetic (PK) approaches, including dermatopharmacokinetics (DPK) and scaled average BE (s-ABE).
Main Results:
- Recommendations for using PK approaches like DPK for topical products.
- Proposal of scaled average BE (s-ABE) considering within-subject variability for highly variable drugs (HVD).
- Discussion on challenges in BE assessment for oral inhalation products and endogenously occurring drugs.
Conclusions:
- Alternative methods and PK approaches are crucial for BE assessment of complex drug products.
- Further research and regulatory considerations are needed for specific drug categories like oral inhalation products.
- The Biopharmaceutics Classification System (BCS) may allow waivers for BE studies in certain cases.
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