Allowable levels of excipients in drug products
Posted: 3 September 2019 | Dave Elder (JPAG Member and David P Elder Consultancy), Fabio Faïs (Auris Medical) | No comments yet
References for ‘Allowable levels of excipients in drug products’, in European Pharmaceutical Review issue 4 2019.
References
- CFR – Code of Federal Regulations Title 21, CFR 210.3(b)(8). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.3. Accessed on 09 July 2019.
- Elder DP, Kuentz M, Holm R. Pharmaceutical excipients — quality, regulatory and biopharmaceutical considerations. Eur J Pharm Sci, 87, 2016, 88-99.
- Rowe R, et al. Handbook of Pharmaceutical Ingredients, 7th Edition, Pharmaceutical Press, London, 2012.
- Aulton ME. Pharmaceutics: The science of dosage form design, Churchill Livingstone Press, London, First Edition, Reprinted 2000.
- Florence AT, Attwood D. Physicochemical Principles of Pharmacy, Pharmaceutical Press, London, Third Edition, 1998, Reprinted 2004.
- FDA Inactive Ingredient Search for Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm. Accessed on 09 July 2019.
- IPEC-Americas Publishes Position Paper on FDA Inactive Ingredient Database. Wednesday, April 22, 2015. https://ipecamericas.org/news/ipec-americas-publishes-position-paper-fda-inactive-ingredient-database. Accessed on 09 July 2019.
- Most Recent Changes to the IID Database. 05/06/2019. https://www.fda.gov/drugs/drug-approvals-and-databases/most-recent-changes-iid-database. Accessed on 09 July 2019.
- Kozarewicz P, Loftsson T. “Novel excipients – regulatory challenges and perspectives – the EU insight” Int J Pharm, Volume 546, Issues 1–2, 30 July 2018, 176-179
