Biowaivers

Biowaivers

Under ANMAT regulations, laboratories holding marketing authorizations for medicinal products containing active pharmaceutical ingredients classified as intermediate risk (Disposition No. 3185/99) must conduct In Vivo or In Vitro Equivalence studies, in accordance with ANMAT Dispositions No. 3185/99, 5330/97, 5040/06, 17406/07 and 758/09.

FP Clinical Pharma —with its specialists in Biopharmaceutics, Bioavailability and Bioequivalence— offers advisory and support to meet these regulatory requirements, with a comprehensive service tailored to the characteristics of each product and the needs of each laboratory:

• Evaluation and Development of Strategies for Biowaiver Requests.
• Preparation of Biowaiver Protocols.
• Management and Follow-up of Permeability Trials.
• Management and Follow-up of Solubility Trials.
• Management and Follow-up of Dissolution Kinetics Studies.
• Pharmacokinetic Support for Permeability Determination.
• Analysis of API-Excipient Interactions-In Vivo Absorption (PK).
• Computational Simulations of In Vivo Trials.
• Supporting Literature for Biowaivers.
• Scientific Writing in Support of Biowaivers.
• Preparation of Results Dossier.
• In Vitro/In Vivo Relationship Analysis.
• Risk Analysis.