Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Chantal Walther"'
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:
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
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
Autor:
Gustavo Mendes Lima Santos, Agnes Chan, Lauren Tesh Hotaki, Kelly Robinson, Dianne Spillman, Laila Sofia Mouawad, Melissa Hunt, Michael Shum, Clare Rodrigues, Ulrich-Peter Rohr, R. Angelo de Claro, Chantal Walther, Richard Pazdur, Yee Hoo Looi, Caroline Healy
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 26(24)
In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries. Project Orbis aims for concurrent submission, r