Post-approval Changes to Drug Substances Guidance for Industry 行业指南：原料药批准后变更 DRAFT GUIDANCE 指南草案 This guidance document is being distributed for comment purposes only.本指南文件仅供公开征求意见 Comments and suggestions regarding this draft document should be submitted within 60 days of ...
药品生产场地分为（1）药品、半成品（in-process materials）、原料药或原料药中间体(drug substance ...
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)Stres 25、s testing of the drug substance can help identify the likely degradation products,...
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 ...
以上8个模块,常用的是(2)Drug Approvals and Databases药品批准情况和数据库(3)Drug Development and Review Process药品开发和审评流程(4)Guidance, Compliance, and Regulatory Information:指南、合规性和监管信息(7)Updates, News, Events, and Training新的审评进展、新产品和新培训课程这四个选项卡,接下来将会...
The changes made in this second revision are listed in the attachment to this guidance. 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 ...
· Changes in the source of the drug substance. ·原料药来源变更 · Changes to the container closure system for the drug substance. ·原料药容器密闭系统变更 This guidance does not address postapproval changes to peptides , oligonucleotides, radiopharmaceuticals; or drug substances isolated from natur...
The changes made in this second revision are listed in the attachment to this guidance. 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 ...
The changes made inthis second revision are listed in the attachment to this guidance.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 ...
Stability-Indicating Assay: A validated quantitative analytical procedure that can detect the changes with time in the pertinent properties (e.g., active ingredient, preservative level) of the drug substance and drug product. A stability-indicating assay accurately measures the active ingredients without...