Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Angelica Dorantes"'
Autor:
Ramana S. Uppoor, Ethan Stier, Dakshina Murthy Chilukuri, Pariban Dhanormchitphong, Mehul Mehta, Tapash Ghosh, Lawrence X. Yu, Haritha Mandula, Paul Seo, Kimberly Raines, Janet Woodcock, Angelica Dorantes, Donna A. Volpe, Dale P. Conner, Jayabharathi Vaidyanathan
Publikováno v:
Molecular pharmaceutics. 14(12)
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientis
Autor:
Angelica Dorantes, Vinod P. Shah, Richard Owen Mannion, Patrick K. Noonan, Colleen Ruegger, Glenn A. Van Buskirk, Bruce Thompson, Ryan MacKenzie, Satish Asotra, Matthew Howard, Theresa Henry, Satyam Upadrashta, Christopher Balducci, Tapash Ghosh, Richard P. Poska, Ramani R. Raghavan, Terrance Ocheltree, Eric Sanchez, Prabir K. Basu, Jason Kamm, Gerald C. DiDonato, Mario A. Gonzalez, Michael L. Putnam, Steven Laurenz, Umesh Pai, Russell Somma, Avinash G. Thombre, Robert Joseph Timko, W. Mark Eickhoff, Vijay Tammara, Sivakumar Vaithiyalingam, Zezhi Jesse Shao
Publikováno v:
AAPS PharmSciTech
In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation
Autor:
Sarah Pope Miksinski, Paul Seo, Tapash Ghosh, John Duan, Zongming Gao, Angelica Dorantes, Poonam Delvadia, Anna Externbrink, Sandra Suarez-Sharp
Publikováno v:
The AAPS journal. 18(3)
Dissolution profile comparisons are used by the pharmaceutical industry to assess the similarity in the dissolution characteristics of two formulations to decide whether the implemented changes, usually minor/moderate in nature, will have an impact o
Publikováno v:
The AAPS Journal
The similarity factor, f2, measures the sameness of dissolution profiles. The following commentary is an overview of discussions and presentations from a group of industry and US regulatory experts that have integrated the science and regulatory rese
Autor:
Angelica Dorantes, Lawrence J. Lesko, Vinod P. Shah, Peter Lockwood, Nicholas Fleischer, Raman K. Baweja, Vijaya Tammara, Houda Mahayni, He Sun, Mohammad Awlad Hossain, Lloyd G. Tillman, Kofi Kumi, Ray Zhu, Venkata Ramana Uppoor, H. Malinowski, Stella Machado, James Henderson, Roger Williams, Hae-Young Ahn, William R. Gillespie, Ting Eng Ong-Chen, Ajaz S. Hussain, Patrick J. Marroum
Publikováno v:
Dissolution Technologies. 4:23-32
Publikováno v:
Pharmaceutical Research. :677-682
The pharmacokinetic and metabolic profile of p-chloro-m-xylenol (PCMX) was studied in healthy mongrel dogs after intravenous and oral administration of single doses of 200 and 2000 mg of PCMX, respectively. Calculation of pharmacokinetic parameters w
Publikováno v:
Analytical Letters. 24:39-53
An enzymatic-high performance liquid chromatography method with electrochemical detection was developed for the quantitation of p-chloro-m-xylenol conjugated metabolites in blood plasma and urine. The method is based on enzymatic hydrolysis of PCMX c
Publikováno v:
Journal of Pharmaceutical Sciences. 83:379-381
A modification of the U.S.P. dissolution method for the quantitation of norethindrone and ethinyl estradiol tablets is proposed. This modification consists of the use of distilled water as the dissolution medium instead of 0.1 N hydrochloric acid (HC
Autor:
Ajaz S. Hussain, Patrick J. Marroum, Hae-Young Ahn, William R. Gillespie, Roger L. Williams, Ting Eng Ong-Chen, Angelica Dorantes, Lawrence J. Lesko, Lloyd G. Tillman, Vinod P. Shah, James Henderson, Ray Zhu, Peter Lockwood, Kofi Kumi, Mohammad Awlad Hossain, H. Malinowski, Nicholas Fleischer, He Sun, Vijaya Tammara, Houda Mahayni, Raman K. Baweja, Venkata Ramana Uppoor, Stella Machado
Publikováno v:
Advances in Experimental Medicine and Biology ISBN: 9781468460384
This draft guidance provides recommendations to pharmaceutical scientists related to various aspects of in vitro/in vivo correlations (IVIVC) for oral extended-release (ER) drug products particularly as utilized in the NDA/ANDA review process. It pre
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::db3724d82fa564702275162c4b571e73
https://doi.org/10.1007/978-1-4684-6036-0_25
https://doi.org/10.1007/978-1-4684-6036-0_25
Publikováno v:
Pharmaceutical Research. :656-657