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Generic Drug Development: A Regulatory and Scientific Guide
Paperback
Business GeneralMedical Reference
Publisher: Independently Published
Published: Jun 10 2026
Pages: 438
Weight: 1.66
Height: 0.89 Width: 7.00 Depth: 10.00
Language: English
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and professional standards, this guide integrates the most recent regulatory updates, including ICH M13A, ICH M13B draft guidance, GDUFA III performance data, and EMA product-specific bioequivalence guidance into a single professionally structured reference.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.
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