Zobrazeno 1 - 10
of 50
pro vyhledávání: '"Ryosuke Kuribayashi"'
Autor:
Eduardo Agostinho Freitas Fernandes, Joy van Oudtshoorn, Andrew Tam, Liliana Carolina Arévalo González, Erwin Guzmán Aurela, Henrike Potthast, Katalina Mettke, Ryosuke Kuribayashi, Kohei Shimojo, Miho Kasuga, Lázaro Morales, Zulema Rodríguez, Ben Jones, Choongyul Ahn, Eunju Yun, So Hee Kim, Clare Rodrigues, Toh Tiong, Christopher Crane, Chantal Walther, Matthias S. Roost, Tzu-Ling Chen, Li-feng Hsu, April C. Braddy, Alfredo García-Arieta, Ivana Abalos, Milly Divinsky, Abdulaziz Alsuwyeh, Bader Alzenaidy, Adel Alharf
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 27 (2024)
Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the rec
Externí odkaz:
https://doaj.org/article/79b11805c0464d5e943c1517544011d9
Autor:
Andrew Tam, Alfredo Garcia-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodriguez Martinez, Milly Divinsky, Rami Kariv, Henrike Potthast, April C. Braddy, Clare Rodrigues, Erwin Guzman Aurela, Liliana Carolina Arevalo Gonzalez, Diego Gutierres Triana, Ben Jones, Choongyul Ahn, Hyuna Kim, So Hee Kim, Ryosuke Kuribayashi, Aya Myoenzono, Kohei Shimojo, Joy van Oudtshoorn, Cornelia Bigler, Ricarda Meincke, Matthias S. Roost, Chantal Walther, Li-feng Hsu, Christopher Crane, Tony Jarman
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 25 (2022)
The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence W
Externí odkaz:
https://doaj.org/article/58dad53dc6254587be848657ec85531f
Autor:
Matthias Shona Roost, Henrike Potthast, Chantal Walther, Alfredo García-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodríguez Martínez, Andrew Tam, Clare Rodrigues, Diego Alejandro Gutierrez Triana, Erwin Guzmán Aurela, Nayive Rodríguez Rodríguez, Sang Aeh Park, Jayoung Kim, Rami Kariv, Milly Divinsky, Ben Jones, Ryosuke Kuribayashi, Aya Myoenzono, Miho Kasuga, Joy van Oudtshoorn, Jo-Feng Chi, Wen-Yi Hung, Li-Feng Hsu, Christopher Crane, Tony Jarman, April Braddy
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 24 (2021)
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release so
Externí odkaz:
https://doaj.org/article/f47a65a70d0c4d7a8b8f9d4102479b05
Autor:
Alfredo Garcia Arieta, Craig Simon, Andrew Tam, Gustavo Mendes Lima Santos, Eduardo Agostinho Freitas Fernandes, Zulema Rodríguez Martínez, Clare Rodrigues, Sang Aeh Park, JaYoung Kim, Kwansoo Kim, Ryosuke Kuribayashi, Aya Myoenzono, Kohei Shimojo, Chantal Walther, Matthias S. Roost, Wen-Yi Hung, Li-feng Hsu, Christopher Crane, April C. Braddy, Joy van Oudtshoorn, Diego Alejandro Gutierrez Triana, Erwin Guzmán Aurela, Ben Jones, Henrike Potthast, Ivana Abalos
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 24 (2021)
The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defi
Externí odkaz:
https://doaj.org/article/8d2cf13caf2d41e48ba25b6cfa407f3b
Autor:
Christopher Crane, Gustavo Mendes Lima Santos, Eduardo Agostinho Freitas Fernandes, Craig Simon, Andrew Tam, Diego Gutierrez Triana, Henrike Potthast, Ryosuke Kuribayashi, Yusuke Okada, Aya Myoenzono, Ivan Omar Calderon, zulema Rodriguez, ben Jones, Sang Aeh Park, So Young Eum, Clare Rodrigues, Joy van Oudsthoorn, Arno Nolting, Chantal Walther, Matthias S Roost, Wen-yi Hung, April C Braddy, Alfredo Garcia-Arieta
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 22, Iss 1 (2020)
In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage forms for which bioequivalence is self-evident (e.g. intravenous solutions), biowaivers bas
Externí odkaz:
https://doaj.org/article/00a5711712b746269509e3272dcbade0
Autor:
Alfredo Garcia Arieta, Craig Simon, Gustavo Mendes Lima Santos, Iván Omar Calderón Lojero, Zulema Rodríguez Martínez, Clare Rodrigues, Sang Aeh Park, Ji Myoung Kim, Ryosuke Kuribayashi, Yusuke Okada, Arno Nolting, Chantal Pfäffli, Wen-Yi Hung, Christopher Crane, April C Braddy, Joy van Oudtshoorn, Diego Gutierrez Triana, Mitch Clarke
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 22, Iss 1 (2019)
The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each juri
Externí odkaz:
https://doaj.org/article/6a32d00a8d9e432d84e4686b21bc7c88
Autor:
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
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 21 (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.
Externí odkaz:
https://doaj.org/article/7773e234e601402ebfce9513edc8be70
Autor:
Maki Matsuhama, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, Kenichi Mikami
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 19, Iss 2 (2016)
Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGD
Externí odkaz:
https://doaj.org/article/3d888c7fe7264308b9409986d14cd9c2
Publikováno v:
Therapeutic Innovation & Regulatory Science. 57:173-177
The Ministry of Health, Labour and Welfare (MHLW) in Japan approved the first generic version of Nasonex in February 2018. The Pharmaceuticals and Medical Devices Agency requires in vitro, pharmacokinetic, and pharmacodynamic or clinical endpoint dat
Publikováno v:
BioDrugs.