Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Aida L. Sanchez"'
Autor:
Bing V. Li, Aida L. Sanchez, Aaron W. Sigler, Hoainhon T. Caramenico, Barbara M. Davit, Santhosh K. Pabba, Sam H. Haidar, Ethan Stier, Christina H. Lee, Dale P. Conner, Chitra Mahadevan
Publikováno v:
The AAPS Journal. 15:10-14
“For-cause” inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and study irregularities are discovered. We investigated the common reasons for
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5988800bb0d669ed1e4dd3a0de95b5cb
https://doi.org/10.1208/s12248-012-9415-9
https://doi.org/10.1208/s12248-012-9415-9
Autor:
Li, Bing V., Davit, Barbara M., Lee, Christina H., Pabba, Santhosh K., Mahadevan, Chitra, Caramenico, Hoainhon T., Haidar, Sam H., Sanchez, Aida L., Sigler, Aaron W., Stier, Ethan M., Conner, Dale P.
Publikováno v:
AAPS Journal; Jan2013, Vol. 15 Issue 1, p10-14, 5p
Autor:
Isadore Kanfer, Leon Shargel
Publikováno v:
Generic Drug Development: Solid Oral Dosage Forms
Introduction to Generic Drug Development Leon Shargel and Izzy Kanfer Active Pharmaceutical Ingredients Edward Cohen and Lih-Yang Lin Analytical Methods Development and Validation Nicholas Cappuccino Experimental Formulation Development Izzy Kanfer,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6eaf62ad726480eae60779bd915f8297
https://doi.org/10.1201/9781420030419
https://doi.org/10.1201/9781420030419
Autor:
Leon Shargel
Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book col