{"product_id":"handbook-of-pharmaceutical-manufacturing-formulations-third-edition-9781138103221","title":"Handbook of Pharmaceutical Manufacturing","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eThe \u003cstrong\u003e\u003cem\u003eHandbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products \u003c\/em\u003e\u003c\/strong\u003eis an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including authorâs own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.\u003c\/p\u003e\u003cp\u003eFeatures:\u003c\/p\u003e\u003cp\u003e Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit \u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003ePart I: Regulatory and Manufacturing Guidance\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eManufacturing Considerations in Liquid Formulations\u003c\/p\u003e\u003cp\u003eOral Solutions and Suspensions\u003c\/p\u003e\u003cp\u003eThe FDA Drug Product Surveillance Program\u003c\/p\u003e\u003cp\u003eChanges to Approved NDAs and aNDAs\u003c\/p\u003e\u003cp\u003eFormulation Considerations of Liquid Products\u003c\/p\u003e\u003cp\u003eContainer Closure Systems\u003c\/p\u003e\u003cp\u003eMaterial for Containers\u003c\/p\u003e\u003cp\u003eStability Testing of New Drug Substances and Products\u003c\/p\u003e\u003cp\u003eStability Testing: Photostability Testing of New Drug Substances and Products\u003c\/p\u003e\u003cp\u003eBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products\u003c\/p\u003e\u003cp\u003eEvaluation of Stability Data\u003c\/p\u003e\u003cp\u003eStability Data Package for Registration Applications in Climatic Zones III and IV\u003c\/p\u003e\u003cp\u003eEU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use\u003c\/p\u003e\u003cp\u003eImpurities: Guideline for Residual Solvents\u003c\/p\u003e\u003cp\u003eElectronic Records and Signatures (CFR 21 Part 11 Compliance)\u003c\/p\u003e\u003cp\u003eProduct-Specific Bioequivalence Testing Protocols\u003c\/p\u003e\u003cp\u003eFormulation Considerations\u003c\/p\u003e\u003cp\u003ePediatric Pharmaceutical EU Legislation\u003c\/p\u003e\u003cp\u003ePediatric Formulations\u003c\/p\u003e\u003cp\u003eSOP and Specification to Establish Electronic Submission to Regulatory Agencies\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003ePart II: Manufacturing Formulations\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003ePart III: Commercial Pharmaceutical Products\u003c\/strong\u003e\u003c\/p\u003e","brand":"CRC Press","offers":[{"title":"Default Title","offer_id":50577805771095,"sku":"9781138103221","price":209.0,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781138103221.jpg?v=1746096772","url":"https:\/\/bookcurl.com\/products\/handbook-of-pharmaceutical-manufacturing-formulations-third-edition-9781138103221","provider":"Book Curl","version":"1.0","type":"link"}