Zobrazeno 1 - 6
of 6
pro vyhledávání: '"João Tavares Neto"'
Autor:
Hye-Na Kang, Robin Thorpe, Ivana Knezevic, Daehyun Baek, Parichard Chirachanakul, Hui Ming Chua, Dina Dalili, Freddie Foo, Kai Gao, Suna Habahbeh, Hugo Hamel, Edwin Nkansah, Maria Savkina, Oleh Semeniuk, Shraddha Srivastava, João Tavares Neto, Meenu Wadhwa, Teruhide Yamaguchi
Publikováno v:
Generics and Biosimilars Initiative Journal. 10:4-32
The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8a7b705e466e297bc0b6dd8c2ec8073b
https://doi.org/10.5639/gabij.2021.1001.002
https://doi.org/10.5639/gabij.2021.1001.002
Autor:
Hui Ming Chua, Mumbi Bernice Chilufya, Parichard Chirachanakul, Jacqueline Rodgers, Maria Savkina, Kai Gao, Hugo Hamel, Violeta Pérez Rodríguez, Suna Habahbeh, João Tavares Neto, Mary Casas Levano, Teruhide Yamaguchi, Hye Na Kang, Gi Hyun Kim, Dina Dalili, Freddie Foo, Oleh Semeniuk, Robin Thorpe, Desi Eka Putri, Ivana Knezevic, Shraddha Srivastava, Meenu Wadhwa
Publikováno v:
Annals of the New York Academy of Sciences
The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6cb8365299a9c97b698ae2a9e92bed8a
https://doi.org/10.1111/nyas.14522
https://doi.org/10.1111/nyas.14522
Autor:
Sam Haidar, Stacy Ho, Lauren Stevenson, Surinder Kaur, Jeff Duggan, Alvydas Mikulskis, Jian Wang, Judy Shih, Magnus Knutsson, Lakshmi Amaravadi, Boris Gorovits, Rand Jenkins, Steve Lowes, Hanlan Liu, Mark Ma, Binodh DeSilva, Ronald Shoup, Emma Whale, Chad Ray, Christopher P. Evans, Marian Kelley, Jean W. Lee, An Song, João Tavares Neto, Bob Nicholson, Laixin Wang, Dominique Gouty, Rafiq Islam, Suzanne Martinez, Mike Losauro, Isabelle Dumont, Adrien Musuku, Dawn Dufield, Vincenzo Pucci, Shefali Patel, Eric Ormsby, Laura Wright, Margarete Brudny-Kloeppel, Valerie Theobald, Gary Schultz, Stephanie Fraser, Timothy V Olah, Noriko Katori, Richard Houghton, Mark E. Arnold, Eric Fluhler, Catherine Dicaire, Eric Woolf, Sherri Dudal, Fabio Garofolo, Jan Welink, Mario Rocci, Laurence Mayrand-Provencher, Heather Myler, Raymond Naxing Xu, Jason Wakelin-Smith, Brian Booth, Roger Hayes, Craig Simon, Surendra Bansal, Theingi M. Thway
Publikováno v:
Bioanalysis. 5:2903-2918
The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::400e67f136ad0c817f027df1f325d6f2
https://doi.org/10.4155/bio.13.238
https://doi.org/10.4155/bio.13.238
Autor:
Binodh DeSilva, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont, France Landry, Catherine Dicaire, Gabriella Szekely-Klepser, Russell Weiner, Mark Arnold, Surendra Bansal, Kevin Bateman, Ronald Bauer, Brian Booth, Scott Davis, Sherri Dudal, Dominique Gouty, John Grundy, Sam Haidar, Roger Hayes, Mohammed Jemal, Surinder Kaur, Marian Kelley, Magnus Knutsson, Olivier Le Blaye, Jean Lee, Steve Lowes, Mark Ma, Toshinari Mitsuoka, João Tavares Neto, Robert Nicholson, Eric Ormsby, Jeffrey Sailstad, Lauren Stevenson, Daniel Tang, Jan Welink, CT Viswanathan, Laixin Wang, Eric Woolf, Eric Yang
Publikováno v:
Bioanalysis. 4:2213-2226
Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, foc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1cbabd89dab1ed5a31301fb38c914809
https://doi.org/10.4155/bio.12.205
https://doi.org/10.4155/bio.12.205
Publikováno v:
Bioanalysis. 6(11)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::188f9cc228d09cd9278514a2a9922c23
https://pubmed.ncbi.nlm.nih.gov/25046041
https://pubmed.ncbi.nlm.nih.gov/25046041
Autor:
Kelen Carine Costa Soares, João Tavares-Neto, Rodrigo Cristofoletti, Camila Fracalossi Rediguieri
Publikováno v:
The AAPS Journal. 16:350-351
We would like to comment on an interesting review article on the similarities and differences among international guidelines for determining bioequivalence (BE) of generic drug products (1). Because the legal framework of the Brazilian Health Surveil
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a561f65509508a5bf813bf8546bc8759
https://doi.org/10.1208/s12248-014-9570-2
https://doi.org/10.1208/s12248-014-9570-2