Results 81 to 90 of about 781 (182)

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications

Clinical and Translational Science, 2019
The waiver of the in vivo demonstration of bioequivalence (biowaiver) is an established tool in drug development and regulatory assessment. This study reviews the use of different biowaiver approaches in centralized applications for marketing ...
Ines Lenić, Kevin Blake, Alfredo Garcia‐Arieta, Henrike Potthast, Jan Welink   +4 more
doaj   +1 more source

What is the role of current mass spectrometry in pharmaceutical analysis?

Mass Spectrometry Reviews, Volume 43, Issue 3, Page 560-609, May/June 2024.
Abstract The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out.
Maria Khalikova, Jakub Jireš, Ondřej Horáček, Michal Douša, Radim Kučera, Lucie Nováková   +5 more
wiley   +1 more source

Comparing Multi-Label Classification Methods for Provisional Biopharmaceutics Class Prediction. [PDF]

, 2014
The biopharmaceutical classification system (BCS) is now well established and utilized for the development and biowaivers of immediate oral dosage forms. The prediction of BCS class can be carried out using multilabel classification.
Taravat Ghafourian, Ghafourian, Taravat, Danielle Newby (1695076), Newby, D., Danielle Newby, Taravat Ghafourian (4466557), Alex Freitas (3762685), Freitas, Alex A., Alex. A. Freitas   +8 more
core   +1 more source

DISSOLUTION PROFILE STUDIES OF BCS CLASS II DRUG VALSARTAN BY BIOWAIVER PROCEDURE

Разработка и регистрация лекарственных средств, 2019
Drug release studies (or in vitro release) of valsartan in three dissolution media simulating the main sections of the gastrointestinal tract were conducted.
E. R. Brigas, E. V. Uspenskaya, V. V. Pisarev   +2 more
doaj  

Dissolution kinetics of propranolol hydrochloride 40 mg tablets under biowaiver conditions [PDF]

Journal of Pharmacy & Pharmacognosy Research
Context: Ensuring the quality of a generic drug is essential for its commercialization. Propranolol hydrochloride is a drug in great demand on the market as it is widely used as an antihypertensive, antianginal, antiarrhythmic, and for the treatment of ...
Lennin R. Rodriguez-Saavedra, Pedro M. Alva-Plasencia, Yuri F. Curo-Vallejos, Segundo F. Saavedra-Suárez, Luis A. Chávez-Abanto, Olga E. Caballero-Aquiño, Miriam E. Gutiérrez-Ramos, Junior F. Sánchez-Bautista   +7 more
doaj   +1 more source

Application of biowaiver tools to combat high-burden diseases

, 2011
The present work comprises different projects within the scope of public health. In detail, they all aim at combating the high-burden diseases HIV/AIDS, malaria and tuberculosis more effectively.
Strauch, Stefanie
core  

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine

, 2022
S.1935-1947Literature relevant to assessing whether BCS-based biowaivers can be applied to immediate release (IR) solid oral dosage forms containing carbamazepine as the single active pharmaceutical ingredient are reviewed.
Shah, V.P., Mehta, M., Groot, D.W., Abrahamsson, B., Dressman, J.B., Tomakazu, T., Langguth, P., Garci­a, M.A., Polli, J.E., Cristofoletti, R., Parr, A.   +10 more
core   +1 more source

A convolution‐based in vitro‐in vivo correlation model for methylphenidate hydrochloride delayed‐release and extended‐release capsule

CPT: Pharmacometrics &Systems Pharmacology, Volume 13, Issue 1, Page 132-142, January 2024.
Abstract Delayed‐release and extended‐release methylphenidate hydrochloride (JORNAY PM®) is a novel capsule formulation of methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder in patients 6 years and older.
Pawan Kumar Gupta, Bev Incledon, Jogarao V. S. Gobburu, Roberto Gomeni   +3 more
wiley   +1 more source

Preparation of biowaiver recommendations for antituberculosis drugs

, 2009
A generic drug product (World Health Organization (WHO) terminology: multisource product) is usually marketed and manufactured after the expiry date of the innovator’s patent.
Becker, Corina
core  

DISSOLUTION MEDIA USED IN DEVELOPMENT AND QUALITY CONTROL OF DRUGS

Разработка и регистрация лекарственных средств, 2019
The main dissolution media recommended for the Dissolution test in Russia and abroad are represented in the review. Possible applications of biorelevant media and media with surfactants are also shown.
O. V. Druzhininskaya, I. E. Smekhova
doaj