Results 161 to 170 of about 781 (182)

Biowaiver studies of newly optimized meloxicam tablets.

Pakistan journal of pharmaceutical sciences, 2019
In this research work biowaiver studies of newly developed and optimized Meloxicam 7.5mg and 15mg water dispersible formulations were carried out at different dissolution media i.e. 0.1N HCl, phosphate buffer pH 4.5, pH 6.8, and pH 7.5 at 50 rpm. For this purpose reference (MA9 and MB9) and tests (MA2, MA4, MA6, MA7 and MA8 (15 mg) and MB2, MB4, MB6 ...
Farya, Zafar, Sohail, Khan, Huma, Ali, Shabana N, Shah, Rabia, Bushra, Ghazala Raza, Naqvi, Kashif, Maroof, Maqsood Ahmed, Khan, Zebun, Nisa   +8 more
openaire   +1 more source

Drug Permeability Studies in Regulatory Biowaiver Applications

2007
The Biopharmaceutics Classification System is a drug development tool that estimates the contributions of solubility, dissolution, and intestinal permeability affecting drug absorption from solid oral products. A regulatory guidance proposes human, animal, and in vitro methods to determine the permeability class membership of a drug substance.
openaire   +1 more source

Biowaivers

2021
openaire   +1 more source

Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help

Biopharmaceutics and Drug Disposition, 2021
Rodrigo Cristofoletti, Amin Rostami-Hodjegan   +1 more
exaly  

Bioequivalence, Pharmaceutical Equivalence, and Biowaivers

2021
openaire   +1 more source

Meeting Report: Dissolution Testing, Biowaiver, and Bioequivalence

Dissolution Technologies, 2020
Vivian A. Gray, Dorys Argelia Diaz, Susan D’Souza   +2 more
openaire   +1 more source

Biowaiver extension potential to BCS Class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet

European Journal of Pharmaceutical Sciences, 2004
Chen-Hsi Chou, Lawrence Yu, Chyun-Yu Yang   +2 more
exaly   +2 more sources

11. Biowaivers

2019
openaire   +1 more source

Automation of Dissolution Tests for Biowaiver Studies

Dissolution Technologies, 2002
openaire   +1 more source

Assessment of the possibility of using comparative in vitro dissolution kinetics (biowaiver) instead of in vivo bioequivalence evaluation for establishing the interchanbeability of generic drugs

Pharmaceutical Chemistry Journal, 2011
Galina Vasilenko, I E Shokhin, G V Ramenskaya   +2 more
exaly