Results 91 to 100 of about 781 (182)

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

Journal of Pharmacy & Pharmaceutical Sciences, 2018
Purpose:  The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions ...
Joy Elizabeth van Oudtshoorn, Alfredo García-Arieta, Gustavo Mendes Lima Santos, Christopher Crane, Clare Rodrigues, Craig Simon, Ji Myoung Kim, Sang Aeh Park, Yusuke Okada, Ryosuke Kuribayashi, Chantal Pfäffli, Arno Nolting, Iván Omar Calderón Lojero, Zulema Rodríguez Martínez, Wen-Yi Hung, April C. Braddy, Nancy Arciniegas Leal, Diego Gutierrez Triana, Mitch Clarke, Peter Bachmann   +19 more
doaj   +1 more source

QbD Application for a Fixed-Dose Combination with Biowaiver Potential: Evaluations of In Vitro and In Vivo Applications

, 2022
Purpose The purpose of this study was to use the quality by design (QbD) approach to design a directly compressed fixed-dose combination (FDC) tablet comprising amlodipine besylate and enalapril maleate with biowaiver potential in alignment with the ...
Yaşın, Diren Sarısaltık, Diren Sarisaltik-Yasin, Abdullah Uslu, Zeynep Safak Teksin, Erdinç, Meral, Emre Uyar, Meral Erdinc, Uyar, Emre, Teksin, Zeynep Şafak, Uslu, Abdullah   +9 more
core   +1 more source

Caco-2 Cells, Biopharmaceutics Classification System (BCS) and Biowaiter

Acta Medica, 2011
Almost all orally administered drugs are absorbed across the intestinal mucosa. The Caco-2 monolayers are used as an in vitro model to predict drug absorption in humans and to explore mechanism of drug absorption.
Libuše Smetanová, Věra Štětinová, Zbyněk Svoboda, Jaroslav Květina   +3 more
doaj   +1 more source

Primary analysis and prioritization of risks of biowaiver procedure

ScienceRise: Pharmaceutical Science, 2016
Aim: To conduct cause-effect analysis of identified risks, ranking and prioritization according to general risk assessment methodology to ensure proper execution of biowaiver procedure in compliance with necessary requirements for its reproduction. Methods: Was used method of cause-effect analysis with construction of Ishikawa diagram.
openaire   +4 more sources

Evaluation of the losartan solubility in the biowaiver context by shake-flask method and intrinsic dissolution

, 2018
This study aimed at evaluating the shake-flask use as a universal method to evaluate drug solubility in a biowaiver context as proposed by FDA, EMA and ANVISA.
Melissa Fabíola Siqueira, Souza, Janine Braga de, Savedra, Melissa Fabíola Siqueira, Lara Maria Lopes de Castro, Souza, Jacqueline de, Ranylson Marcello Leal Savedra, Jacqueline de Souza, Janine Braga de Souza, Neila Márcia Silva-Barcellos, Savedra, Ranylson Marcello Leal, Castro, Lara Maria Lopes de   +10 more
core   +1 more source

Biowaiver monographs for immediate-release solid oral dosage forms : Zidovudine (azidothymidine)

, 2013
Literature data on the properties of zidovudine relevant to waiver of in vivo bioequivalence (BE) testing requirements for the approval of immediate-release (IR) solid oral dosage forms containing zidovudine alone or in combination with other active ...
Langguth, Peter, Soares, Kelen C C, Shah, Vinod P, Groot, D W, Rediguieri, Camila F, Abrahamsson, Bertil,, Souza, Jacqueline, Dressman, Jennifer, Kopp, Sabine, Polli, James E, Serra, Cristina Helena R   +10 more
core   +1 more source

Estudo do polimorfismo em diferentes fármacos de interesse para a indústria farmacêutica [PDF]

, 2011
Dissertação (mestrado) - Universidade Federal de Santa Catarina, Centro de Ciências Biológicas. Programa de Pós-Graduação em FarmacologiaÉ sabido que os sólidos farmacêuticos podem existir em mais de uma forma sólida, as quais podem exibir diferentes ...
Limberger, Ana Luiza Marin Bortoluzzi
core  

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate.

, 2017
Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics according
Langguth, Peter, Alan Parr, Peter Langguth, Uthpali Mannapperuma, Jennifer Dressman, Groot, Dirk W, Priyadarshani Galappatthy, Jayakody, Lal, Parr, Alan, Rodrigo Cristofoletti, Dirk W. Groot, Shah, Vinod P, Lal Jayakody, Mehul Mehta, Mannapperuma, Uthpali, Cristofoletti, Rodrigo, Dressman, Jennifer, Thambavita, Dhanusha, Vinod P. Shah, Dhanusha Thambavita, Bertil Abrahamsson, Abrahamsson, Bertil, Mehta, Mehul, Galappatthy, Priyadarshani, Polli, James E, James E. Polli   +25 more
core   +1 more source

Equilibrium solubility versus intrinsic dissolution: characterization of lamivudine, stavudine and zidovudine for BCS classification

Brazilian Journal of Pharmaceutical Sciences, 2013
Solubility and dissolution rate of drugs are of major importance in pre-formulation studies of pharmaceutical dosage forms. The solubility improvement allows the drugs to be potential biowaiver candidates and may be a good way to develop more dose ...
André Bersani Dezani, Thaisa Marinho Pereira, Arthur Massabki Caffaro, Juliana Mazza Reis, Cristina Helena dos Reis Serra   +4 more
doaj   +1 more source

COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

International Journal of Drug Regulatory Affairs, 2018
To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study.
Vaishali Kothari, Priti Mehta, Jimi Patel   +2 more
openaire   +2 more sources