Drug Stability: Principles and Practices

✍ Scribed by Jens T. Carstensen, Christopher Rhodes

Publisher: CRC Press
Year: 2000
Tongue: English
Leaves: 793
Series: Drugs and the Pharmaceutical Sciences
Edition: 3rd
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

✦ Table of Contents

Contents......Page 14
Preface......Page 12
Contributors......Page 16
1. Introductory Overview......Page 20
2. Solution Kinetics......Page 38
3. Kinetic pH Profiles......Page 76
4. Oxidation in Solution......Page 132
5. Catalysis, Complexation, and Photolysis......Page 152
6. Solid State Stability......Page 164
7. Interactions of Moisture with Solids......Page 210
8. Physical Characteristics of Solids......Page 228
9. Performulation......Page 256
10. Physical Testing......Page 280
11. Development and Validation of HPLC Stability-Indicating Assays......Page 348
12. Stability Testing of Clinical Trial Materials......Page 404
13. A Rational Approach to Stability Testing and Analytical Development for NCE, Drug Substance, and Drug Products: Marketed Product Stability Testing......Page 434
14. Packaging, Package Evaluation, Stability, and Shelf-Life......Page 502
15. Industrial Stability Testing in the United States and Computerization of Stability Data......Page 534
16. Stability of Polypeptides and Proteins......Page 572
17. Regulatory Aspects of Stability Testing in Europe......Page 598
18. Regulatory and Scientific Aspects of Stability Testing: Present and Possible Future Trends......Page 638
Appendix: Guidance for Industry: Stabilty Testing of Drug Substances and Drug Products (Draft)......Page 656
B......Page 770
C......Page 772
F......Page 773
G......Page 774
I......Page 775
K......Page 776
L......Page 777
M......Page 778
O......Page 779
R......Page 780
S......Page 781
V......Page 783
Y......Page 784
Z......Page 785
C......Page 786
H......Page 787
M......Page 788
P......Page 789
S......Page 790
W......Page 791
Z......Page 792

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