Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products

Author:

Allain Leonardo,Baertschi Steven W.,Clapham David,Foti Chris,Lantaff Wendy M.,Reed Robert A.,Templeton Allen C.,Tønnesen Hanne Hjorth

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference37 articles.

1. 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;Baertschi;J Pharm Sci,2013

2. Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 2: topical drug products;Baertschi;J Pharm Sci,2015

3. Stability of frusemide tablets repackaged in dose administration aids;Bowen;J Pharm Prac Res,2007

4. United States Pharmacopoeia 38-NF33 (http://www.usp.org/) EMC web site (http://www.medicines.org.uk). Accessed March 26, 2016.

5. ICH Q1B, Stability testing: photostability testing of new drug substances and products. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/. Accessed March 26, 2016.

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