新药原料及制剂稳定性试验研究

潇湘子

Stability Testing of New Drug Substances  and Products


TABLE OF CONTENTS



I.  INTRODUCTION (1) ................................................................................................1
A.  Objectives of the Guidance (1.1).............................................................................................................1
B.  Scope of the Guidance (1.2) .....................................................................................................................2
C.  General Principles (1.3)............................................................................................................................2
II.  GUIDANCE (2)..........................................................................................................2
A.  Drug Substance (2.1) .................................................................................................................................2
1. General (2.1.1)..............................................................................................................................................2
2.  Stress Testing (2.1.2)...................................................................................................................................3
3.  Selection of Batches (2.1.3) ........................................................................................................................3
4. Container Closure System (2.1.4)..............................................................................................................3
5.  Specification (2.1.5).....................................................................................................................................3
6. Testing Frequency (2.1.6)...........................................................................................................................4
7.  Storage Conditions (2.1.7)..........................................................................................................................4
8.  Stability Commitment (2.1.8) ......................................................................................................................6
9. Evaluation (2.1.9).........................................................................................................................................7
B.  Drug Product (2.2) .....................................................................................................................................8
1. General (2.2.1)..............................................................................................................................................8
2. Photostability Testing (2.2.2) .....................................................................................................................8
3.   Selection of Batches (2.2.3) .......................................................................................................................8
4. Container Closure System (2.2.4)..............................................................................................................8
5.  Specification (2.2.5).....................................................................................................................................9
6. Testing Frequency (2.2.6)...........................................................................................................................9
7.  Storage Conditions (2.2.7)........................................................................................................................10
8.  Stability Commitment (2.2.8) ....................................................................................................................14
9. Evaluation (2.2.9).......................................................................................................................................15
10.   Statements/Labeling (2.2.10) .................................................................................................................16
GLOSSARY (3) .............................................................................................................. 17
REFERENCES (4) .......................................................................................................... 21
ATTACHMENT  List Of Revision 2 Changes.................................................................. 22

咕咕

能翻译成中文不？

sunwng

欺负我英文不好

总统特使

年龄大了，英文不好，有中文就好了

咕咕

你找找看，应声很大哦。

xxcc2050

v谢谢楼主分享啊

hldmfw

感谢分享