Particle size distribution: PSD of drug substance Lot #2 was measured using Malvern Mastersizer. The results were as follows: d10 – 7.2 μm; d50 – 12 μm; d90 – 20 μm. This is representative of the drug substance PSD selected for the final drug product formulation. 粒度分布:使用Malv...
另外，点击图19中“Guidances”，可获得FDA最近颁布的指导原则。▲ 图-19 2.5 Drug Establishments Current Registration Site Search（药物公司注册地址数据库）当药品包装上无生产商信息或无生产商具体地址时，应如何在FDA网站上查找公司地址？1）第一种情况，在药品包装（可通过DailyMed网站查找药品包装）上可以明确...
20、ntal factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.The choice of test conditions defined in this guidance is based on an analysis of the effects of climati...
2.7 Product-Specific Guidances for Generic Drug Development(特殊产品开发指南)点击“图3”中“Product-Specific Guidances for Generic Drug Development”进行检索。 ▲图-27 直接点击上图中“Montelukast Sodium”即可查找药物BE指导原则草案,如下图所示。在BE指导原则草案中需要特别关注额外说明,例如孟鲁司特钠咀嚼...
for industry Dissolution Testing and Acceptance Criteria forImmediate-Release Solid Oral Dosage Form Drug Products Containing HighSolubility Drug Substances (August 2018). The information/data supporting thehigh solubility of the drug substance(s), as described in the BCS guidance (ICHguidance for ...
II. GUIDANCE (2) A. Drug Substance (2.1) 1. General (2.1.1) Information on the stability of the drug substance is an integral part of the systematic approach to stability evaluation. 2. Stress Testing (2.1.2) Stress testing of the drug substance can help identify the likely degradation ...
A. Objectives of the Guidance (1.1) This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration application within the three regions of the European Union (EU), Japan, and the United States. It does not seek...
A. Objectives of the Guidance (1.1)This guidance is intended to define what stability data package for a new drug substance or drugproduct is sufficient for a registration application within the three regions of the European Union(EU), Japan, and the United States. It does not seek to ...
draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug ...
示例1显示了NDSRI,即N-Nitroso-L-nebivolol的活性指数计算方法: 示例2的NDSRI为N-nitroso-ketamine 原文链接:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related...