{ "item_title" : "Generic Drug Development", "item_author" : [" Saddam Nawaz "], "item_description" : "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 approvalBioequivalence Science - In-depth analysis including the ICH M13A guideline and the M13B draft for additional strengths biowaiversGDUFA III Commitments - How updated performance goals reshape generic drug review timelines and submission strategyGlobal GMP Compliance - Essential frameworks across FDA 21 CFR Parts 210/211, EMA EudraLex Volume 4, and WHO GMP standardsSide-by-Side Regulatory Comparisons - Direct breakdowns of FDA vs EMA vs WHO vs ICH requirements across every major topicComplex Generics - Technical guidance on inhalation, topical, liposomal, and drug-device combination productsLifecycle Management - Post-approval changes, patent exclusivities, authorised generics, and biosimilars via the 351(k) pathwayGlobal 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and professional standards, this guide integrates the most recent regulatory updates, including ICH M13A, ICH M13B draft guidance, GDUFA III performance data, and EMA product-specific bioequivalence guidance into a single professionally structured reference.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.", "item_img_path" : "https://covers4.booksamillion.com/covers/bam/9/79/819/959/9798199593335_b.jpg", "price_data" : { "retail_price" : "27.99", "online_price" : "27.99", "our_price" : "27.99", "club_price" : "27.99", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }

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