{"product_id":"new-drug-approval-process-richard-a-guarino-9781420088496","title":"New Drug Approval Process","description":"\u003cp\u003eThe thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.\u003c\/p\u003e\u003cp\u003eUpdated chapters include: \u003c\/p\u003e\u003cul\u003e \u003cul\u003e \u003c\/ul\u003e \u003cli\u003eadvances in international regulatory requirements, including ICH guidelines and harmonization\u003c\/li\u003e \u003cli\u003ea step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs\u003c\/li\u003e \u003cli\u003ethe latest regulatory requirements for expediting new drug approvals\u003c\/li\u003e \u003cli\u003estrategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development\u003c\/li\u003e \u003c\/ul\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Richard A. Guarino\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1420088491\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781420088496\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 06\/01\/2009\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 548\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.90lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.20w x 1.30d","brand":"Richard A. Guarino","offers":[{"title":"Hardcover","offer_id":48113501503743,"sku":"9781420088496","price":265.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_938d6803-a697-4009-8671-390f0e67e3e4.jpg?v=1769615444","url":"https:\/\/www.whiterainbookhouse.com\/products\/new-drug-approval-process-richard-a-guarino-9781420088496","provider":"WR Book House","version":"1.0","type":"link"}