AAPS Open Forum Report: Proposals for Regulatory Harmonization of a Global BCS Framework: Challenges and Opportunities
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Initially, the WHO considered granting biowaivers for some drugs of weak acids in Class II.
“Initially, the WHO also considered granting biowaivers for some drugs of weak acids in Class II (13) but presently grants biowaivers for only Class I and Class III drugs.”
From BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements (2016) · cites this paper as [13]
The WHO presently grants biowaivers for only Class I and Class III drugs.
“Initially, the WHO also considered granting biowaivers for some drugs of weak acids in Class II (13) but presently grants biowaivers for only Class I and Class III drugs.”
From BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements (2016) · cites this paper as [13]
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Cites
Takagi, T., Ramachandran, C., Bermejo, M., Yamashita, S., Yu, L. X., & Amidon, G. L. (2006) · Molecular Pharmaceutics · doi:10.1021/mp0600182 · Cited by 607 · see citing works
WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Yin, H., Hetzke, J., Kozarewicz, P., et al. (1969) · PubMed · Cited by 262 · see citing works
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BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements
Davit, B. M., Kanfer, I., Tsang, Y. C., & Cardot, J.-M. (2016) · The AAPS Journal · doi:10.1208/s12248-016-9877-2 · Cited by 92 · see citing works
Self-citation
- Authors
- Kanfer, I.
- Affiliations
- Rhodes University (ZA)
- Corresponding author
- Kanfer, Isadore
- ORCID
- Kanfer, Isadore
- Venue
- Dissolution Technologies
- Publisher
- Dissolution Technologies
- Published
- 2015
- Volume
- 22
- Issue
- 2
- Pages
- 58-65
- ISSN
- 1521-298X (ISSN-L)
- OpenAlex
- W2604931437
- Cited by
- 3
- References
- 3
- Citations by year
- 2021: 1 · 2020: 1 · 2016: 1
- FWCI
- 0.18
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Dissolution Technologies (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- regulatory harmonization, biowaiver, bioequivalence, generic drug approval, regulatory science, dissolution testing, drug regulation
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