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Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences)
0Original price was: ₹4,995.00.₹3,996.00Current price is: ₹3,996.00.Discover the essential guide to Generic Drug Product Development: Specialty Dosage Forms from The Bookish Owl. This critical resource delves into demonstrating pharmaceutical and bioequivalence for complex drug products. Explore scientific methods and regulatory pathways for manufacturers aiming to prove therapeutic equivalence to branded alternatives. The book covers vital aspects of drug product quality, performance measurement, and specific requirements for topical, nasal, inhalation, and transdermal systems, alongside generic biologics and modified-release parenterals. Essential for pharmaceutical scientists, researchers, and regulators, this book by CRC Press is your key to navigating the development of specialty generic drugs.
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Genetic Drug Product Development Drugs And The Pharm Sci Vol 201 (Hb 2010) (Special Indian Edition): International Regulatory Requirements for Bioequivalence (Drugs and the Pharmaceutical Sciences)
0Original price was: ₹3,995.00.₹3,196.00Current price is: ₹3,196.00.Explore the essential ‘International Regulatory Requirements for Bioequivalence’ in Genetic Drug Product Development Drugs And The Pharm Sci Vol 201. This crucial volume from The Bookish Owl addresses the global surge in generic and multi-source drug products, driven by the need for affordable therapies. Learn how to navigate complex national and international laws to ensure quality and therapeutic equivalence to brand-name alternatives. Essential for pharmaceutical scientists and regulatory professionals, this book details worldwide legislative frameworks, critical for drug product registration and market access, especially in countries with limited inspection resources. Optimize your drug development strategy with this indispensable guide.