Zobrazeno 1 - 10
of 46
pro vyhledávání: '"Zulema Rodríguez"'
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:
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:
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:
Fernando Achiong Alemañy, Migdalia Cobas Pérez, Fernando Achiong Estupiñán, Berta Bello Rodríguez, Jana Fernández Alfonso, Zulema Rodríguez Betancourt
Publikováno v:
Revista Médica Electrónica, Vol 34, Iss 5, Pp 531-547 (2012)
En Cuba las enfermedades del corazón constituyen la principal causa de muerte desde hace más de cuatro décadas. En la actualidad fallecen cada año más de 20 000 personas, fundamentalmente por la alta letalidad debido al infarto agudo del miocard
Externí odkaz:
https://doaj.org/article/0b2ff0024b9d4923916d15049b70992f
Autor:
Gholian-Jouybari, Fatemeh, Hajiaghaei-Keshteli, Mostafa, Smith, Neale R., Calvo, Ericka Zulema Rodríguez, Mejía-Argueta, Christopher, Mosallanezhad, Behzad
Publikováno v:
In Applied Soft Computing January 2024 150
Autor:
Salehi-Amiri, Amirhossein, Zahedi, Ali, Gholian-Jouybari, Fatemeh, Calvo, Ericka Zulema Rodríguez, Hajiaghaei-Keshteli, Mostafa
Publikováno v:
In Applied Mathematical Modelling January 2022 101:600-631
Autor:
Fernando Achiong Alemañy, Migdalia Cobas Pérez, Fernando Achiong Estupiñán, Berta Bello Rodríguez, Jana Fernández Alfonso, Zulema Rodríguez Betancourt
Publikováno v:
Revista Médica Electrónica, Vol 34, Iss 5, Pp 531-547
En Cuba las enfermedades del corazón constituyen la principal causa de muerte desde hace más de cuatro décadas. En la actualidad fallecen cada año más de 20 000 personas, fundamentalmente por la alta letalidad debido al infarto agudo del miocard
Externí odkaz:
https://doaj.org/article/17d39d7d32d944379564c71e3fe56204
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