Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Sang-Aeh Park"'
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:
Henrike Potthast, Ben Jones, Rami Kariv, Andrew Tam, Chantal Walther, Zulema Rodríguez Martínez, Clare Rodrigues, Miho Kasuga, Matthias Shona Roost, Sang Aeh Park, Joy Van Oudtshoorn, Erwin Guzmán Aurela, Ivana Abalos, Jo-Feng Chi, Milly Divinsky, April C Braddy, Jayoung Kim, Gustavo Mendes Lima Santos, Nayive Rodríguez Rodríguez, Wen-Yi Hung, Tony Jarman, Diego Alejandro Gutierrez Triana, Aya Myoenzono, Eduardo Agostinho Freitas Fernandes, Alfredo García-Arieta, Ryosuke Kuribayashi, Li-Feng Hsu, Christopher Crane
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 22, Iss 1 (2020)
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://explore.openaire.eu/search/publication?articleId=doi_dedup___::9db25d77a243634055cea2b954128c2e
https://doi.org/10.18433/jpps30724
https://doi.org/10.18433/jpps30724
Autor:
Eduardo Agostinho Freitas Fernandes, Alfredo Garcia Arieta, Kohei Shimojo, Ryosuke Kuribayashi, Ivana Abalos, Chantal Walther, Li-Feng Hsu, Wen-Yi Hung, Andrew Tam, Zulema Rodríguez Martínez, Clare Rodrigues, Erwin Guzmán Aurela, Diego Alejandro Gutierrez Triana, Aya Myoenzono, Sang Aeh Park, Jayoung Kim, April C Braddy, Gustavo Mendes Lima Santos, Craig Simon, Henrike Potthast, Matthias Shona Roost, Joy Van Oudtshoorn, Christopher Crane, Ben Jones, Kwansoo Kim
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://explore.openaire.eu/search/publication?articleId=doi_dedup___::fd0478ea0dd9a1c93beb2add328c38e4
https://pubmed.ncbi.nlm.nih.gov/33734975
https://pubmed.ncbi.nlm.nih.gov/33734975
Autor:
April C Braddy, Arno Nolting, Gustavo Mendes Lima Santos, Sang Aeh Park, Yusuke Okada, Wen-Yi Hung, Mitchell R. Clarke, Alfredo Garcia Arieta, Chantal Pfäffli, Joy Van Oudtshoorn, Christopher Crane, Ji Myoung Kim, Ryosuke Kuribayashi, Zulema Rodríguez Martínez, Clare Rodrigues, Craig Simon, Iván Omar Calderón Lojero, Diego Alejandro Gutierrez Triana
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://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c87d25c0eeae53e1160b6dc174a4204
https://pubmed.ncbi.nlm.nih.gov/30599818
https://pubmed.ncbi.nlm.nih.gov/30599818
Autor:
Roost, Matthias S., Potthast, Henrike, Walther, Chantal, García-Arieta, Alfredo, Abalos, Ivana, Freitas Fernandes, Eduardo Agostinho, Lima Santos, Gustavo Mendes, Rodríguez Martínez, Zulema, Tam, Andrew, Rodrigues, Clare, Gutierrez Triana, Diego Alejandro, Guzmán Aurela, Erwin, Rodríguez Rodríguez, Nayive, Sang Aeh Park, Jayoung Kim, Kariv, Rami, Divinsky, Milly, Jones, Ben, Ryosuke Kuribayashi, Aya Myoenzono
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences; 2021, Vol. 24, p548-562, 15p
Autor:
Arno Nolting, Peter Bachmann, Iván Omar Calderón Lojero, Diego Alejandro Gutierrez Triana, Wen-Yi Hung, April C Braddy, Craig Simon, Nancy Arciniegas Leal, Ji Myoung Kim, Gustavo Mendes Lima Santos, Joy Van Oudtshoorn, Ryosuke Kuribayashi, Yusuke Okada, Christopher Crane, Mitchell R. Clarke, Sang Aeh Park, Zulema Rodríguez Martínez, Chantal Pfäffli, Clare Rodrigues, Alfredo García-Arieta
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://explore.openaire.eu/search/publication?articleId=doi_dedup___::2fc15358b0a25116fd9678144d20b50b
https://doi.org/10.18433/j3x93k
https://doi.org/10.18433/j3x93k