Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Raltegravir Potassium

Author:

Kambayashi AtsushiORCID,Iida Masaki,Ishihara Makoto,Takahashi Yoshinori,Abrahamsson Bertil,Charoo Naseem A.ORCID,Cristofoletti Rodrigo,Langguth Peter,Mehta Mehul,Parr AlanORCID,Polli James E.,Shah Vinod P.,Dressman Jennifer

Publisher

Elsevier BV

Reference31 articles.

1. United States Food and Drug Administration. SUPAC-IR: immediate-release solid oral dosage forms: scale-up and post-approval changes: chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation.; 1995. Accessed January 30, 2024.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-ir-immediate-release-solid-oral-dosage-forms-scale-and-post-approval-changes-chemistry

2. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. ICH harmonized guideline: biopharmaceutics classification system-based biowaivers M9. 2019. Accessed August 15, 2023. https://database.ich.org/sites/default/files/M9_Guideline_Step4_2019_1116.pdf

3. World Health Organization. WHO model list of essential medicines - 23rd list. 2023. Accessed August 15, 2023. https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02

4. Advanced HIV disease and health-related suffering—exploring the unmet need of palliative care;Rangaraj;Lancet HIV,2023

5. Raltegravir (MK-0518): a novel integrase inhibitor for the treatment of HIV infection;Anker;Expert Opin Investig Drugs,2008

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