Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 1: Drug Products Administered by Injection-Reference-Cited by-同舟云学术

Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 1: Drug Products Administered by Injection

Published:2013-11 Issue:11 Volume:102 Page:3888-3899
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Baertschi Steven W.,Clapham David,Foti Chris,Jansen Patrick J.,Kristensen Solveig,Reed Roberta.,Templeton Allen C.,Tonnesen Hanne Hjorth

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference34 articles.

1. Pharmaceutical photostability: A technical guide and practical interpretation of the ICH guideline and its application to pharmaceutical stability;Thatcher;Pharm Technol Part II,2001

2. ICH guidelines for photostability testing;Aman;Aspects and directions of use. Pharmazie,2003

3. Photostability studies of drug substances and products. Practical implications of the ICH guideline;Sequeira;Pharm Techol,2000

4. Commentary: A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B);Baertschi;J Pharm Sci,2010

5. Practical considerations for effectively conducting pharmaceutical photostability testing;Templeton;Am Pharm Rev,2007

Cited by 38 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Exploring novel and fast stability or sameness evaluation tool for different categories of injectable formulations;European Journal of Pharmaceutical Sciences;2023-11

2. A Survey on Handling and Administration of Therapeutic Protein Products in German and Swiss Hospitals;Journal of Pharmaceutical Sciences;2023-09

3. Study of the Effect of Eudragit RSPO on the Photostability of Venlafaxine in a Physical Mixture and in a Melt Form;Processes;2023-08-18

4. Primary Processes of Free Radical Formation in Pharmaceutical Formulations of Therapeutic Proteins;Biomolecules;2023-07-17

5. Effect of light source and UVA quotient on monoclonal antibody stability during ambient light exposure studies;European Journal of Pharmaceutics and Biopharmaceutics;2023-04