{"product_id":"b0gxw22sgr","title":"Generic Drug Development: A Regulatory and Scientific Guide","description":"\u003cp\u003eAre you navigating the complex world of generic drug development and approval?\u003c\/p\u003e\n\n\u003cp\u003eGeneric 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.\u003c\/p\u003e\n\n\u003cp\u003eWhat this book covers:\u003c\/p\u003e\n\n\u003cp\u003eThe 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:\u003c\/p\u003e\n\n\u003cp\u003eWritten 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and professional standards, this guide integrates the most recent regulatory updates, including ICH M13A, ICH M13B draft guidance, GDUFA III performance data, and EMA product-specific bioequivalence guidance into a single professionally structured reference.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.\u003c\/p\u003e\n\n\u003cp\u003eWhether 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.\u003c\/p\u003e\n\n\u003cp\u003eIdeal for:  Regulatory affairs professionals · ANDA applicants · Pharmaceutical scientists · Graduate students in pharmacy and pharmaceutical sciences · Quality assurance and GMP specialists\u003c\/p\u003e\n\n\u003cp\u003eEquip yourself with the ultimate regulatory desk reference. Order your copy today.\u003c\/p\u003e","brand":"ANT","offers":[{"title":"Ebook","offer_id":67924884160757,"sku":"YSL54366","price":5.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/8774\/8597\/files\/61a-LVeSb2L._SY1500.jpg?v=1793673815","url":"https:\/\/www.newbooks.store\/products\/b0gxw22sgr","provider":"NewBooks","version":"1.0","type":"link"}