Zobrazeno 1 - 10
of 599
pro vyhledávání: '"Biowaiver"'
Publikováno v:
Pharmaceutical Science Advances, Vol 2, Iss , Pp 100020- (2024)
Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System
Externí odkaz:
https://doaj.org/article/e9f2ea8fcea54ad69a125770d0e823bb
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 1, Pp 42-52 (2024)
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 featur
Externí odkaz:
https://doaj.org/article/82ae18b02df645fb9464495a3d62b9a7
Autor:
Nedaa Alomari, Waleed Alhussaini
Publikováno v:
Frontiers in Pharmacology, Vol 15 (2024)
Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence. The evaluation of bioequi
Externí odkaz:
https://doaj.org/article/32b4b72b7a0c4ebeb0d525abbfe8044e
Autor:
Sekar Ayu Pawestri
Publikováno v:
Journal of Food and Pharmaceutical Sciences, Pp 763-769 (2023)
Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies. V
Externí odkaz:
https://doaj.org/article/ddb41a3990f3465a98cbc70cc121f21b
Publikováno v:
Pharmaceutics, Vol 15, Iss 11, p 2523 (2023)
The Caco-2 cell line derived from human colon carcinoma is commonly used to assess the permeability of compounds in in vitro conditions. Due to the significant increase in permeability studies using the Caco-2 cell line in recent years, the need to s
Externí odkaz:
https://doaj.org/article/19cc1185abf14af9ae3ed530048d6a4f
Autor:
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
Publikováno v:
Ars Pharmaceutica, Vol 62, Iss 4, Pp 358-370 (2021)
Abstract 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 publishe
Externí odkaz:
https://doaj.org/article/5eaa577d75e54bba8fe4405c5f78aee5
Akademický článek
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Autor:
Ping Ren, Theresa Chan, Wen-Cheng Yang, Mitchell Frost, Yan Wang, Markham Luke, Myong-Jin Kim, Robert Lionberger, Yi Zhang
Publikováno v:
Pharmaceutics, Vol 15, Iss 9, p 2366 (2023)
One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and
Externí odkaz:
https://doaj.org/article/671453aa31f540588579982b4b729154
Autor:
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
Publikováno v:
Brazilian Journal of Pharmaceutical Sciences, Vol 58 (2022)
Abstract 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 Surveillanc
Externí odkaz:
https://doaj.org/article/540e57a372c94b18858904d29903ec8a
Publikováno v:
Hemijska Industrija, Vol 74, Iss 6, Pp 389-397 (2020)
The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships between
Externí odkaz:
https://doaj.org/article/17b2e23f13114b2382dfab94e9333321