Challenges in Bioequivalence Evaluation of Special Dosage Forms. Vinod P. Shah, Ph. D. Pharmaceutical Consultant III Symposium Sindusfarma – IPS-FIP - ANVISA
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Challenges in Bioequivalence Evaluation of Special Dosage Forms
Vinod P. Shah, Ph. D. Pharmaceutical Consultant
III Symposium Sindusfarma – IPS-FIP - ANVISA
New Frontiers in Manufacturing Technology, Regulatory
Brasilia, Brazil. August 4-5, 2014
What are Complex Drugs?
Guidance on Equivalence of Special Dosage Forms
Orally administered non-absorbed drugs
2 studies – fasting and fed 4-way, fully replicated crossover design in vivo Bioequivalence based on 90% Confidence Interval
Propose to use 4 metrics
Cmax, AUC0-T AUCT-t AUC∞
AUC0-T should compare T & R exposure responsible for early onset of response
AUCT-t should compare T & R exposure responsible for sustained response
All metrics should meet BE limits (80-125)
FDA: Pharm Sci Advisory Committee meeting: April 2010
The FDA approach for demonstrating BE of DPI’s
---- Weight of Evidence ----
Stepwise approach in EMA guideline
Phase 3 similar?
HVD, NTI, Topical, Inhalation