Comprehensive Guide to Bioavailability and Bioequivalence Studies - Tapa blanda

Sinopsis

This book provides a comprehensive and practical guide to the scientific and regulatory principles governing bioavailability (BA) and bioequivalence (BE) studies in Brazil. Recognized as essential components of pharmaceutical development, BA/BE studies support the approval of generic, similar, and innovative medicines by demonstrating comparable therapeutic performance, ensuring product quality, patient safety, and clinical efficacy. The book consolidates ANVISA's extensive regulatory framework, including recent updates such as RDC No. 742/2022 and RDC No. 941/2024, into a single, accessible reference. Beyond summarizing regulations, it explains their scientific basis, practical application, and regulatory significance. Covering the complete lifecycle of BA/BE studies-from pharmacokinetic fundamentals, study design, volunteer management, ethical considerations, pharmaceutical equivalence, and bioanalytical method validation to statistical analysis, inspection readiness, and regulatory submission-this resource bridges theory and practice.

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