Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Milly Divinsky"'
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:
Katerina Shulman, Ilana Weiss, Matitiahu Berkovitch, Shai Ashkenazi, Moshe E Gatt, Osnat Luxenburg, Stephany Hiayev, Einat Shacham-Shmueli, Michal Hirsch Vexberg, Rami Hershkowitz, Einat Gorelik, Haim Mayan, Yehudit Steinmetz, Noa Berar Yanai, Orly Schlissel, Muhammad Azem, Neriya Gutgold, Milly Divinsky, Nirit Yarom, Alla Vishkautzan, Chezi Ganzel, Lidia Arcavi, Eli Marom, Biatrice Uziely, Shoshana Zevin, Hadar Meirow, Denize Ainbinder
Publikováno v:
BMJ Open, Vol 13, Iss 5 (2023)
Objectives US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Me
Externí odkaz:
https://doaj.org/article/5182d1f30202403fba42ed308f75acff
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:
Stephany Hiayev, Einat Shacham-Shmueli, Matitiahu Berkovitch, Ilana Weiss, Shai Ashkenazi, Michal Hirsch Vexberg, Rami Hershkowitz, Einat Gorelik, Haim Mayan, Yehudit Steinmetz, Noa Berar Yanai, Orly Schlissel, Muhammad Azem, Neriya Gutgold, Katerina Shulman, Milly Divinsky, Nirit Yarom, Alla Vishkautzan, Chezi Ganzel, Moshe E Gatt, Lidia Arcavi, Eli Marom, Biatrice Uziely, Shoshana Zevin, Hadar Meirow, Osnat Luxenburg, Denize Ainbinder
Publikováno v:
BMJ Open. 13:e067313
ObjectivesUS FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Med
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