{"product_id":"generic-drug-product-development-solid-oral-dosage-forms-9781420086355","title":"Generic Drug Product Development: Solid Oral Dosage Forms","description":"\u003cp\u003e • Author(s): Leon Shargel\u003cbr\u003e • Publisher: Taylor \u0026amp; Francis\u003cbr\u003e • Publisher Imprint: CRC Press\u003cbr\u003e • BISAC: Pharmacy\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eIn this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cb\u003eGeneric Drug Product Development: Solid Oral Dosage Forms, Second Edition\u003c\/b\u003e presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products--from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. \u003cp\u003e\u003c\/p\u003eMajor topics discussed include: \u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eActive pharmaceutical ingredients\u003c\/li\u003e \u003cli\u003eExperimental formulation development, including a new section on Quality by Design (QbD)\u003c\/li\u003e \u003cli\u003eScale-up\u003c\/li\u003e \u003cli\u003eCommercial product formulation\u003c\/li\u003e \u003cli\u003eQuality control and bioequivalence\u003c\/li\u003e \u003cli\u003eDrug product performance\u003c\/li\u003e \u003cli\u003eANDA regulatory process\u003c\/li\u003e \u003cli\u003ePost-approval changes\u003c\/li\u003e \u003cli\u003ePost-marketing surveillance\u003c\/li\u003e \u003cli\u003eLegislative and patent challenges \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eThis second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.\u003c\/p\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Hardcover","offer_id":45236431421591,"sku":"9781420086355","price":18852.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781420086355.webp?v=1769212999","url":"https:\/\/atlanticbooks.com\/products\/generic-drug-product-development-solid-oral-dosage-forms-9781420086355","provider":"Atlantic Books","version":"1.0","type":"link"}