Výsledky vyhledávání - "Chi Yan J. Tam"

Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities

Autor: Alison P. Bailey, Adeyma Arroyo, Melissa Alvarez, Pao Lin Che, Chi Yan J. Tam

Publikováno v: PDA journal of pharmaceutical science and technology. 74(4)

Cleaning validation acceptance criteria in multiproduct facilities are established using maximum allowable carryover calculations. Carryover calculations incorporate the shared equipment surface area between two products to ensure that an acceptable

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e35ad62f00b8c45b48b23e0a0c8ef03
https://pubmed.ncbi.nlm.nih.gov/32179711

Zobrazit plný text záznamu

Accelerating drug development: methodology to support first-in-man pharmacokinetic studies by the use of drug candidate microdosing

Autor: Robert M. Ings, Christopher L Holliman, Gerald R. Galluppi, Matthew A. McLean, Chi-Yan J. Tam, Michael T. Baratta

Publikováno v: Drug Development Research. 68:14-22

Microdosing of experimental therapeutics in humans offers a number of benefits to the drug development process. Microdosing, conducted under an exploratory Investigational New Drug (IND) application, entails administration of a sub-pharmacological do

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::dedd03534dd4ac0d6af9d7a41078b2c2
https://doi.org/10.1002/ddr.20160

Zobrazit plný text záznamu

Su2082 Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Amg 181, a Fully Human Anti-α4β7 Antibody for Treating Inflammatory Bowel Diseases (IBD)

Autor: Dominique C. Borie, Kai O. Reynhardt, Christine M. Evangelista, Susanna Dodson, Kefei Zhou, Larry C. Wienkers, William A. Rees, Peter J. Prince, Mark Yen, Sonal K. Patel, Christine A. Haller, Chi-Yan J. Tam, Hailing Hsu, David R. Doherty, Wei-Jian Pan, Zhigang Yu, Wen Gu, Barbara A. Sullivan

Publikováno v: Gastroenterology. 142:S-565

Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Amg 181, a Fully Human Anti-α4β7 Antibody for Treating Inflammatory Bowel Diseases (IBD) Wei-Jian Pan, Barbara A. Sullivan, Christine M. Evangelista, David R. Doherty, Chi-Yan J. Tam, Sona

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2b4cad06d03e53cc9beaa25372f13fac
https://doi.org/10.1016/s0016-5085(12)62170-2

Zobrazit plný text záznamu

Akademický článek

Accelerating drug development: methodology to support first‐in‐man pharmacokinetic studies by the use of drug candidate microdosing.

Autor: Matthew A. McLean, Chi‐Yan J. Tam, Michael T. Baratta, Christopher L. Holliman, Robert M. Ings, Gerald R. Galluppi

Publikováno v: Drug Development Research; Feb2007, Vol. 68 Issue 1, p14-22, 9p

Zobrazit plný text záznamu

Vyhledávací nástroje:

Upřesnit hledání