Found: 6
Select item for more details and to access through your institution.
Reconciling sprinkle administration information in approved NDA labeling with sprinkle bioequivalence study recommendations in FDA product-specific guidances for generic drug development.
- Published in:
- American Journal of Pharmacotherapy & Pharmaceutical Sciences, 2022, p. 1, doi. 10.25259/AJPPS_18_2022
- By:
- Publication type:
- Article
Reconciling sprinkle administration information in approved NDA labeling with sprinkle bioequivalence study recommendations in FDA product-specific guidances for generic drug development.
- Published in:
- American Journal of Pharmacotherapy & Pharmaceutical Sciences, 2022, p. 1, doi. 10.25259/AJPPS_18_2022
- By:
- Publication type:
- Article
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme.
- Published in:
- 2019
- By:
- Publication type:
- journal article
A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme.
- Published in:
- Journal of Pharmacy & Pharmaceutical Sciences, 2018, v. 21, p. 27, doi. 10.18433/j3x93k
- By:
- Publication type:
- Article
Integration of mass spectrometry into early-phase discovery and development of central nervous system agents.
- Published in:
- Journal of Mass Spectrometry, 2001, v. 36, n. 11, p. 1211, doi. 10.1002/jms.227
- By:
- Publication type:
- Article
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications.
- Published in:
- AAPS Journal, 2023, v. 25, n. 2, p. 1, doi. 10.1208/s12248-023-00797-3
- By:
- Publication type:
- Article