CTD格式要求(英文版).doc

2. 3. P DRUG PRODUCT (NAME, DOSAGE FORM) 2.3.P.1 Description and Composition of the Drug Product （1）A description of the dosage of drug product and its composition should be provided with a table to present the action of each composition and the specification. Overages should be explained and the dissolvent which is used but removed in the end should be in the table. Composition amount Overages action specification the dissolvent which is used but removed in the end (2) If there is special dissolvent, please fill the table as above. (3) Description of container and material of package. 2.3.P.2 Pharmaceutical Development Summarize the purpose of the development, including dosage, strength and reason of the selection. 2.3.P.2.1 Components of the Drug Product 2.3.P.2.1.1 Drug substance Summarize the compatibility of the drug substance with excipients. Refer to 3.2.P.2.1.1 (Page: ) for the details. Additionally, summarize key physicochemical characteristics (e.g., solubility, particle size distribution, or crystal form) of the drug substance that can influence the performance of the drug product and also the control of all this characteristics. 2.3.P.2.1.2 Excipients Generally introduce the types and the tests and/ or reference of amount selection. Refer to 3.2.P.2.1.2 (Page: ) for the details. 2.3.P.2.2 Pharmaceutical Development 2.3.P.2.2.1 Formulation Development Refer to 3.2.P.2.2.1(Page: ) for the process of formulation development and supporting information. A tabulated summary of the variation and reasons of formulation of different development steps, as well as supporting validation tests should be provided. For example: Formulation of laboratory scale tests Formulation of pilot scale tests Formulation of large scale tests Main variation and reasons Supporting information Excessive feeding: Supporting information about excessive feeding. 2.3.P.2.2.2 Properties of drug products Summary relevant to the performance o