Results 101 to 110 of about 781 (182)

RETROSPECTIVE OF DISSOLUTION TEST OF SOLID DOSAGE FORMS (REVIEW)

Разработка и регистрация лекарственных средств, 2019
The article describes the main historical stages in the development of the science of drug dissolution and the dissolution profile test from the theoretical foundations of dissolution, developed in the first half of the 20th century, and the development ...
D. Yu. Grebenkin, Ya. M. Stanishevskiy, I. E. Shohin, E. A. Malashenko   +3 more
doaj  

Biowaiver: Rabeprazole and Its Reproducible Analogs [PDF]

Effective Pharmacotherapy, 2020
O.V. Kalinina, I.E. Smekhova, S.V. Okovitiy, N.V. Bakulina, O.I. Solovyeva, I.G. Bakulin   +5 more
openaire   +1 more source

Biowaiver monographs for immediate-release solid oral dosage forms: Stavudine

, 2012
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing stavudine (d4T) are reviewed.
Storpirtis, Silvia, Silva, Arthur L. L., Shah, Vinod P., Barends, Dirk M., Dressman, Jennifer B., Stavchansky, Salomon, Cristofoletti, Rodrigo, Sousa, Varley D., Junginger, Hans E.   +8 more
core   +1 more source

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.

, 2017
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the marketing authorization of immediate-release, solid oral dosage forms containing enalapril maleate are reviewed.
Langguth, Peter, Raimar Löbenberg, Alan Parr, D.W. Groot, Shah, Vinod P, Groot, D W, Mehul Mehta, Peter Langguth, Cristofoletti, Rodrigo, Roger K. Verbeeck, Kanfer, Isadore, Jennifer B. Dressman, Isadore Kanfer, Vinod P. Shah, Verbeeck, Roger K, Parr, Alan, Bertil Abrahamsson, Dressman, Jennifer B, Abrahamsson, Bertil, Mehta, Mehul, Rodrigo Cristofoletti, Polli, James E, James E. Polli, Löbenberg, Raimar   +23 more
core   +1 more source

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective. [PDF]

CPT Pharmacometrics Syst Pharmacol, 2023
Manolis E, García-Arieta A, Lindahl A, Kotzagiorgis E, Limberg J, Holte Ø, Paixao P, Versantvoort C, Tshinanu FM, Blake K, Van Den Heuvel M.   +10 more
europepmc   +1 more source

Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation

, 2009
The aim of the present study was to use gastrointestinal simulation technology and in vitro-in vivo correlation (IVIVC) as tools to investigate a possible extension of biowaiver criteria to BCS class II drugs using carbamazepine (CBZ) as a candidate ...
Homšek, Irena, Langguth, Peter, Parojčić, Jelena, Kovacević, Ivan, Tubić-Grozdanis, Marija   +4 more
core   +1 more source

Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium

31373144The present monograph discusses the possibility of BCS-based biowaivers for immediate release pharmaceutical products containing raltegravir potassium, which is used to treat human immunodeficiency virus (HIV) infections.
Langguth, Peter, Takahashi, Yoshinori, Abrahamsson, Bertil S.I., Charoo, Naseem Ahmad, Ishihara, Makoto, Polli, James E., Shah, Vinod P., Cristofoletti, Rodrigo, Parr, Alan F., Iida, Masaki, Dressman, Jennifer B., Mehta, Mehul U., Kambayashi, Atsushi   +12 more
core   +1 more source

Biowaiver study of oral tabletted ethylcellulose microcapsules of a BCS class I drug

Bulletin of the Chemical Society of Ethiopia, 2009
This article describes the preparation and characterization (in vitro and in vivo) of three different sustained-release salbutamol sulfate−ethylcellulose tabletted microparticles (T1, T2 and T3) and reference sustained release tablet (Ventolin 8 mg
Ghulam Murtaza, Mahmood Ahmad, Naveed Akhtar   +2 more
doaj  

BIOWAIVER IN THE GENERIC DRUG REGISTRATION SYSTEM: A NARRATIVE REVIEW OF INTERNATIONAL REGULATORY REQUIREMENTS AND PROSPECTS FOR APPLICATION IN THE REPUBLIC OF KAZAKHSTAN

Introduction. A biowaiver assesses the bioequivalence of generic medicinal products using the Biopharmaceutics Classification System and comparative in vitro dissolution studies.
Anel Azamatova, Gulbaram Ustenova, Serzhan Mombekov   +2 more
core   +1 more source

Emerging Role of Biopharmaceutical Classification and Biopharmaceutical Drug Disposition System in Dosage form Development: A Systematic Review. [PDF]

Turk J Pharm Sci, 2022
Samineni R, Chimakurthy J, Konidala S.
europepmc   +1 more source