Ragupathy Renganathan

Pharma Sprint 30 - IVIVC Skill Burst (eBook, ePUB)

• Format: ePub

Produktbeschreibung

Pharma Sprint 30 IVIVC Skill Burst is a compact, practical guide designed for pharma professionals and students. It focuses on In VitroIn Vivo Correlation (IVIVC) to help predict drug absorption and bioavailability. The book covers 30 essential skills, each with detailed explanations and practical examples. It integrates dissolution testing, pharmacokinetic modelling, and predictive techniques. Regulatory aspects from FDA, EMA, and CDSCO are discussed for submission readiness. Case studies illustrate oral, modified-release, and parenteral formulations. Practical insights help with formulation optimization, bioequivalence waivers, and post-approval changes. The book emphasizes QbD principles, troubleshooting, and statistical validation. It is ideal for formulation scientists, QA/QC professionals, and regulatory affairs specialists. A must-have guide to accelerate learning and practical application of IVIVC in real-world pharma.

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Produktdetails

• Verlag: Ragupathy Renganathan
• Erscheinungstermin: 6. November 2025
• Englisch
• ISBN-13: 9798232746421
• Artikelnr.: 75836038