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 volume Why 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and professional standards, this guide integrates the most recent regulatory updates, including ICH M13A, ICH M13B draft guidance, GDUFA III performance data, and EMA product-specific bioequivalence guidance into a single professionally structured reference.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 specialists

Equip yourself with the ultimate regulatory desk reference. Order your copy today.