{"product_id":"international-pharmaceutical-product-registration-9781420081763","title":"International Pharmaceutical Product Registration","description":"\u003cp\u003e • Author(s): Anthony C. Cartwright | Brian R. Matthews\u003cbr\u003e • Publisher: CRC Press\u003cbr\u003e • Publisher Imprint: CRC Press\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eDiscover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.\u003c\/p\u003e\u003cp\u003eThe recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.\u003c\/p\u003e\u003cp\u003eThis cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.\u003c\/p\u003e\u003cp\u003eThe book is organized into six highly practical segments: \u003c\/p\u003e\u003cul\u003e \u003cul\u003e \u003c\/ul\u003e \u003cli\u003ePart I: CTD, eCTD, Module 1, and Environmental Risk Assessment\u003c\/li\u003e \u003cli\u003ePart II: CTD Summaries\u003c\/li\u003e \u003cli\u003ePart III: Quality Topics\u003c\/li\u003e \u003cli\u003ePart IV: Nonclinical Topics\u003c\/li\u003e \u003cli\u003ePart V: Clinical Topics\u003c\/li\u003e \u003cli\u003ePart VI: Other Topics (including drug-device combination products)\u003c\/li\u003e \u003cul\u003e \u003c\/ul\u003e \u003c\/ul\u003e\u003cp\u003eThis text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.\u003c\/p\u003e","brand":"CRC Press","offers":[{"title":"Hardcover","offer_id":46931693863063,"sku":"9781420081763","price":16540.0,"currency_code":"INR","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781420081763.webp?v=1771615466","url":"https:\/\/atlanticbooks.com\/products\/international-pharmaceutical-product-registration-9781420081763","provider":"Atlantic Books","version":"1.0","type":"link"}