{"product_id":"drug-development-roadmap-mirela-gorjanu-9798284006979","title":"Drug Development Roadmap: From Lab Bench to Pharmacy Shelf","description":"\u003cp\u003e\u003cb\u003e\u003ci\u003eDrug Development Roadmap: From Lab Bench to Pharmacy Shelf\u003c\/i\u003e \u003c\/b\u003eis a comprehensive, real-world guide to the full lifecycle of pharmaceutical development-from early discovery to commercial launch. Written for scientists, regulatory professionals, formulation experts, and industry newcomers, this resource demystifies the drug development process with clarity and technical depth.\u003c\/p\u003eDrawing from more than two decades of global industry experience, author Mirela Gorjanu presents a step-by-step framework that spans target identification, preclinical studies, GMP manufacturing, analytical method development, clinical trials, regulatory submissions, and post-marketing surveillance.\u003cbr\u003eWith Cardiovex-a fictitious case study drug-woven throughout, the book bridges theoretical concepts with practical execution, covering topics such as: \u003cul\u003e\n\u003cli\u003eAnalytical method development (HPLC, LC-MS\/MS, dissolution)\u003c\/li\u003e\n\u003cli\u003eGMP scale-up, packaging, and stability strategy\u003c\/li\u003e\n\u003cli\u003eClinical trials, bioequivalence, and regulatory submission formats (CTD\/eCTD)\u003c\/li\u003e\n\u003cli\u003eRisk management, pharmacovigilance, and lifecycle control\u003c\/li\u003e\n\u003cli\u003eChange control, serialization, and global pharmacy launch planning\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eAligned with ICH, FDA, EMA, and WHO standards, this reference equips readers to navigate complex regulatory environments and build quality into every phase of development. Whether you're launching a new molecule or reformulating a generic, this roadmap delivers the insights and tools needed to accelerate innovation while ensuring compliance and patient safety.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Mirela Gorjanu\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798284006979\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/15\/2025\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 104\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.33lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.22d","brand":"Mirela Gorjanu","offers":[{"title":"Paperback","offer_id":48014172193023,"sku":"9798284006979","price":9.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_32df58d6-c6f3-41fc-84c7-4e3d972b04ff.jpg?v=1767747138","url":"https:\/\/www.whiterainbookhouse.com\/products\/drug-development-roadmap-mirela-gorjanu-9798284006979","provider":"WR Book House","version":"1.0","type":"link"}