Assessing impact of manufacturing and package configurations to photosensitive compounds-Reference-Cited by-同舟云学术

Assessing impact of manufacturing and package configurations to photosensitive compounds

Published:2015-10-12 Issue:6 Volume:42 Page:936-944
ISSN:0363-9045
Container-title:Drug Development and Industrial Pharmacy
language:en
Short-container-title:Drug Development and Industrial Pharmacy

Author:

Carvalho Thiago C.¹,Escotet Megerle L.¹,Lin Judy²,Sprockel Omar L.¹

Affiliation:

1. Drug Product Science & Technology, Bristol-Myers Squibb, Co., New Brunswick, NJ, USA and

2. Analytical and Bioanalytical Development, Bristol-Myers Squibb, Co., New Brunswick, NJ, USA

Publisher

Informa UK Limited

Subject

Organic Chemistry,Drug Discovery,Pharmaceutical Science,Pharmacology

Link

https://www.tandfonline.com/doi/pdf/10.3109/03639045.2015.1091472

Reference35 articles.

1. ICH Expert Working Group. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Stability Testing: Photostability Testing of New Drug Substances and Products Q1B; 1996 Nov 6

2. The role of degradant profiling in active pharmaceutical ingredients and drug products☆

3. Development of forced degradation and stability indicating studies of drugs—A review

4. Forced Degradation of Therapeutic Proteins

5. Best Practices for Drug Substance Stress and Stability Studies During Early-Stage Development Part II—Conducting Abbreviated Long-Term and Accelerated Stability Testing on the First Clinical Drug Substance Batch to Confirm and Adjust the Drug Substance Retest Period/Powder for Oral Solution Shelf Life

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