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Handbook of bioequivalence testing / Sarfaraz K. Niazi New York : Informa Healthcare USA, 2007602 tr. ; 27 cm.Cung cấp kiến thức chuyên sâu về cách đánh giá hiệu quả sinh học giữa thuốc generic và thuốc gốc, bao gồm cả thuốc nhỏ phân tử và sinh học (biosimilars), đồng thời giới thiệu các xu hướng hiện đại như miễn trừ BE (biowaiver), ứng dụng công nghệ và cải cách quy trình để giảm chi phí và thời gian phát triển thuốc. Đây là nguồn tài liệu thiết yếu cho các chuyên gia nghiên cứu và phát triển dược phẩm
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Handbook of pharmaceutical manufacturing formulations : Volume 1: Compressed Solid Products / Sarfaraz K. Niazi Boca Raton : CRC Press, 2020593 tr. ; cm.The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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
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Handbook of pharmaceutical manufacturing formulations : Volume 2: Uncompressed Solid Products / Sarfaraz K. Niazi Boca Raton : CRC Press, 2020457 tr. ; cm.The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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
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Handbook of pharmaceutical manufacturing formulations : Volume 3: Liquid Products / Sarfaraz K. Niazi Boca Raton : CRC Press, 2020457 tr. ; cm.The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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
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Handbook of pharmaceutical manufacturing formulations : Volume 4: Semisolid Products / Sarfaraz K. Niazi Boca Raton : CRC Press, 2020503 tr. ; cm.The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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
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