Results 11 to 20 of about 781 (182)

Biowaiver as a Bioequivalence Study Option [PDF]

Регуляторные исследования и экспертиза лекарственных средств, 2023
SCIENTIFIC RELEVANCE. Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features ...
E. A. Volkova, Yu. V. Medvedev, E. N. Fisher, I. E. Shohin   +3 more
doaj   +3 more sources

ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries [PDF]

Pharmaceutics, 2021
The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development.
Claudia Miranda, Alexis Aceituno, Mirna Fernández, Gustavo Mendes, Yanina Rodríguez, Verónica Llauró, Miguel Ángel Cabrera-Pérez   +6 more
doaj   +3 more sources

Biopharmaceutics classification system: importance and inclusion in biowaiver guidance [PDF]

Brazilian Journal of Pharmaceutical Sciences, 2015
Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population.
Lorena Barbosa Arrunátegui, Neila Márcia Silva-Barcellos, Karime Rezende Bellavinha, Lisiane da Silveira Ev, Jacqueline de Souza   +4 more
doaj   +3 more sources

Comparator product issues for biowaiver implementation: the case of Fluconazole

Brazilian Journal of Pharmaceutical Sciences, 2022
The aim of this work was to assess if the commercially available Fluconazole drug products (Reference, Generic and Similar) would meet the biowaiver criteria from Food and Drug Administration (FDA) and Brazilian Agency for Health Surveillance (ANVISA ...
Raul Edison Luna Lazo, Lilian Klein Teleginski, Aline Biggi Maciel, Marcos Antônio Segatto Silva, Cassiana Mendes, Larissa Sakis Bernardi, Fábio Seigi Murakami, Fabio Sonvico, Paulo Renato Oliveira   +8 more
doaj   +4 more sources

Comparison of in vitro, in vivo, and in silico bioavailability results of different prednisone tablet formulations to assess the feasibility of possible biowaiver

Ars Pharmaceutica, 2021
Introduction: The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process. This work aims to compare in vitro, in silico, and in vivo data to establish if previously published prednisone
Leonardo Henrique Toehwé, Thiago da Silva Honorio, Luiz Claudio Rodrigues Pereira da Silva, Thalita Martins da Silva, Luciana da Rocha Pitta, Livia Deris Prado, Lucio Mendes Cabral, Helvécio Vinícius Antunes Rocha   +7 more
doaj   +3 more sources

Challenges obtaining a biowaiver for topical veterinary dosage forms [PDF]

Journal of Veterinary Pharmacology and Therapeutics, 2012
Baynes, R., Riviere, J., Franz, T., Monteiro‐Riviere, N., Lehman, P., Peyrou, M., Toutain, P.‐L. Challenges obtaining a biowaiver for topical veterinary dosage forms.J. vet. Pharmacol. Therap.35(Suppl. 1), 103–114.Obtaining a biowaiver for topical drugs used in veterinary species faces many of the same challenges associated with human topicals. However,
Baynes, Ronald E, Riviere, Jim, Franz, Thomas, Monteiro-Riviere, Nancy A, Lehman, Paul, Peyrou, Mathieu, Toutain, Pierre-Louis   +6 more
openaire   +6 more sources

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report [PDF]

CPT: Pharmacometrics & Systems Pharmacology, 2023
This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao   +17 more
doaj   +2 more sources

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Prednisone [PDF]

Journal of Pharmaceutical Sciences, 2007
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 prednisone are reviewed. Due to insufficient data prednisone cannot be definitively classified according to the current Biopharmaceutics Classification System (BCS) criteria as ...
Vogt, M, Derendorf, H, Krämer, J, Junginger, HE, Midha, KK, Shah, VP, Stavchansky, S, Dressman, JB, Barends, DM   +8 more
openaire   +8 more sources

Utility of in vitro release testing (IVRT) to assess ‘sameness’ of 1% clotrimazole creams for use as a biowaiver

AAPS Open, 2023
The October 2022 draft United States Food and Drug Administration (FDA) guidance presents an option of in vitro release test (IVRT) studies as a biowaiver for topical drug products submitted in abbreviated new drug applications (ANDAs).
Hannah Wellington, Seeprarani Rath, Sagaran Abboo, Isadore Kanfer   +3 more
doaj   +2 more sources

Evaluation of Excipient Risk in BCS Class I and III Biowaivers. [PDF]

AAPS J, 2022
AbstractThe objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability.
Metry M, Polli JE.
europepmc   +4 more sources