Generic Drug Development: A Regulatory and Scientific Guide

Are you navigating the complex world of generic drug development and approval?Generic Drug Development: A Regulatory and Scientific Guide is the most current comprehensive reference available for pharmaceutical industry professionals, regulatory affairs specialists, and graduate-level researchers who need practical, up-to-date guidance on bringing generic medicines to market globally.What this book covers: - The Complete ANDA Pathway - From initial patent strategy through FDA review, deficiency response, and final approval- Bioequivalence Science - In-depth analysis including the ICH M13A guideline and the M13B draft for additional strengths biowaivers- GDUFA III Commitments - How updated performance goals reshape generic drug review timelines and submission strategy- Global GMP Compliance - Essential frameworks across FDA 21 CFR Parts 210/211, EMA EudraLex Volume 4, and WHO GMP standards- Side-by-Side Regulatory Comparisons - Direct breakdowns of FDA vs EMA vs WHO vs ICH requirements across every major topic- Complex Generics - Technical guidance on inhalation, topical, liposomal, and drug-device combination products- Lifecycle Management - Post-approval changes, patent exclusivities, authorised generics, and biosimilars via the 351(k) pathway- Global Registration - WHO Prequalification, CDSCO, ANVISA, and multi-market registration strategy in a single volumeWhy this book stands out: Written at strict academic and professional standards, this guide integrates the most recent regulatory updates, including ICH M13A, ICH M13B draft guidance, GDUFA III performance data, and EMA product-specific bioequivalence guidance into a single professionally structured reference. Every chapter includes learning objectives, regulatory comparison tables, key points summaries, and fully cited scholarly references.Whether you are preparing an ANDA submission, designing a bioequivalence study, managing a global regulatory dossier, or building a career in pharmaceutical regulatory affairs, this book is your essential desk reference.Ideal for: Regulatory affairs professionals - ANDA applicants - Pharmaceutical scientists - Graduate students in pharmacy and pharmaceutical sciences - Quality assurance and GMP specialistsEquip yourself with the ultimate regulatory desk reference. Order your copy today.

Pagina's: 436, Paperback, Independently published