Found: 9
Select item for more details and to access through your institution.
Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons.
- Published in:
- European Journal of Clinical Pharmacology, 2015, v. 71, n. 9, p. 1083, doi. 10.1007/s00228-015-1889-9
- By:
- Publication type:
- Article
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
- Published in:
- European Journal of Clinical Pharmacology, 2012, v. 68, n. 12, p. 1611, doi. 10.1007/s00228-012-1396-1
- By:
- Publication type:
- Article
Global Harmonization of Comparator Products for Bioequivalence Studies.
- Published in:
- AAPS Journal, 2017, v. 19, n. 3, p. 603, doi. 10.1208/s12248-017-0068-6
- By:
- Publication type:
- Article
Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen.
- Published in:
- Chirality, 2020, v. 32, n. 9, p. 1169, doi. 10.1002/chir.23258
- By:
- Publication type:
- Article
Importation and distribution of unregistered medicines in the public sector: similarities, differences, and shared challenges among Southern African Development Community (SADC) countries.
- Published in:
- 2022
- By:
- Publication type:
- journal article
Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework.
- Published in:
- EJNMMI Radiopharmacy & Chemistry, 2024, v. 8, n. 1, p. 1, doi. 10.1186/s41181-023-00230-2
- By:
- Publication type:
- Article
Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products.
- Published in:
- Frontiers in Medicine, 2024, p. 1, doi. 10.3389/fmed.2024.1394562
- By:
- Publication type:
- Article
Needs‐driven talent and competency development for the next generation of regulatory scientists in Africa.
- Published in:
- British Journal of Clinical Pharmacology, 2022, v. 88, n. 2, p. 579, doi. 10.1111/bcp.15020
- By:
- Publication type:
- Article
Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union.
- Published in:
- Pharmaceutics, 2023, v. 15, n. 2, p. 601, doi. 10.3390/pharmaceutics15020601
- By:
- Publication type:
- Article