Drug Products:The finished dosage form (tablet,capsule,etc.) that contains a drug substance--generally,but not necessarily,in association with other active or inactive ingredients. 简言之,前者就是那些可以药用的物质,比如人参、枸杞或其它化学物质.而后者只是最终制成的你可以服用的药,它们可以含drug ...
Drug substance:The active ingredient intended to diagnose,treat,cure,or prevent disease or affect the structure or function of the body,excluding other inactive substances used in the drug product.Drug Products:The finished dosage form (tablet,capsule,etc.) that contains a drug substance--generally...
Drug substance:The active ingredient intended to diagnose,treat,cure,or prevent disease or affect the structure or function of the body,excluding other inactive substances used in the drug product.Drug Products:The finished dosage form (tablet,capsule,etc.) that contains a drug substance--generally...
ICH Q8 defines QbD as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management”.9 The Food and Dr...
在生物药的生产过程中,原液(Drug Substance, DS)和制剂(Drug Product, DP)是两个重要且关键的环节,它们各自有着不同的关注点和挑战: 01 原液(DS)生产 重点 DS的生产通常集中在生物反应器中进行,涉及细胞培养、蛋白质表达和初步的纯化步骤。 目标 提高生产效率和降低成本。这可能包括优化生物反应条件、提高细胞密...
FDA,GMP,ICH临床实验专业英语词汇互译 ... drug product: 药物产品drug substance:原料药established name: 确定的名 … www.360doc.com|基于106个网页 2. 为原料药 药品注册... ... drug product 制剂。 (drug substance为原料药) drug production/ manufacture and distribution 药品生产和流 … ...
document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug ...
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protocols, the results of the stability studies, the protocols for any future stability testing, commitment to carry out future stability testing, and analysis of the stability data to indicate the conclusions as to retest date (for the drug substance) or shelf life (for the drug product). The...
ANDAs: Stability Testing of Drug Substances and Products- Industry Perspective Nick Cappuccino, Jr., Ph.D., Vice President Scientific Affairs..