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Debra Birnkrant

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Regulatory Toxicology and Pharmacology : RTP|September 29, 2009
Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.AKuei-Meng Wu, Jinhui Dou, Hanan Ghantous, et al.
Gastroenterology|August 1, 2017
Public-Private Partnership: Targeting Real-World Data for Hepatitis C Direct-Acting AntiviralsPoonam Mishra, Jeffry Florian, Joy Peter, et al.
Journal of Clinical Pharmacology|October 1, 2010
Antiviral Information Management System (AIMS): a prototype for operational innovation in drug developmentPravin R Jadhav, Lauren Neal, Jeff Florian, et al.
Journal of Virus Eradication|November 9, 2019
Sustained virological response rates with direct-acting antivirals in black subjects with HCV genotype 1 infection: systematic analysis of clinical trialsKimberly Struble, Kirk Chan-Tack, Karen Qi, et al.
Gastroenterology|March 9, 2013
Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapiesJianmeng Chen, Jeffry Florian, Wendy Carter, et al.
Proceedings (Baylor University. Medical Center)|June 24, 2024
Clinical fellowship augmented by regulatory review experience: a perspective on the Children's National Hospital/FDA fellowship tracksJency Daniel, Nicholas Geagan, Nada Harik, et al.
Journal of Clinical Pharmacology|September 23, 2022
Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development ProgramKirk Chan-Tack, Mario Sampson, Justin Earp, et al.
Gastroenterology|December 3, 2014
FDA perspective on sofosbuvir therapy for patients with chronic hepatitis C virus genotype 1 infection who did not respond to treatment with pegylated interferon and ribavirinPoonam Mishra, Jeffry Florian, Karen Qi, et al.
The Lancet. Infectious Diseases|March 12, 2019
Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpoxKirk M Chan-Tack, Patrick R Harrington, Su-Young Choi, et al.
MMWR. Morbidity and Mortality Weekly Report|December 21, 2023
Evaluation of SARS-CoV-2 RNA Rebound After Nirmatrelvir/Ritonavir Treatment in Randomized, Double-Blind, Placebo-Controlled Trials - United States and International Sites, 2021-2022Patrick R Harrington, Jie Cong, Stephanie B Troy, et al.
Pageof 3

Showing results (11-20 of 24) with videos related to

Sort By:
Pageof 3
Regulatory Toxicology and Pharmacology : RTP|September 29, 2009
Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.AKuei-Meng Wu, Jinhui Dou, Hanan Ghantous, et al.
Gastroenterology|August 1, 2017
Public-Private Partnership: Targeting Real-World Data for Hepatitis C Direct-Acting AntiviralsPoonam Mishra, Jeffry Florian, Joy Peter, et al.
Journal of Clinical Pharmacology|October 1, 2010
Antiviral Information Management System (AIMS): a prototype for operational innovation in drug developmentPravin R Jadhav, Lauren Neal, Jeff Florian, et al.
Journal of Virus Eradication|November 9, 2019
Sustained virological response rates with direct-acting antivirals in black subjects with HCV genotype 1 infection: systematic analysis of clinical trialsKimberly Struble, Kirk Chan-Tack, Karen Qi, et al.
Gastroenterology|March 9, 2013
Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapiesJianmeng Chen, Jeffry Florian, Wendy Carter, et al.
Proceedings (Baylor University. Medical Center)|June 24, 2024
Clinical fellowship augmented by regulatory review experience: a perspective on the Children's National Hospital/FDA fellowship tracksJency Daniel, Nicholas Geagan, Nada Harik, et al.
Journal of Clinical Pharmacology|September 23, 2022
Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development ProgramKirk Chan-Tack, Mario Sampson, Justin Earp, et al.
Gastroenterology|December 3, 2014
FDA perspective on sofosbuvir therapy for patients with chronic hepatitis C virus genotype 1 infection who did not respond to treatment with pegylated interferon and ribavirinPoonam Mishra, Jeffry Florian, Karen Qi, et al.
The Lancet. Infectious Diseases|March 12, 2019
Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpoxKirk M Chan-Tack, Patrick R Harrington, Su-Young Choi, et al.
MMWR. Morbidity and Mortality Weekly Report|December 21, 2023
Evaluation of SARS-CoV-2 RNA Rebound After Nirmatrelvir/Ritonavir Treatment in Randomized, Double-Blind, Placebo-Controlled Trials - United States and International Sites, 2021-2022Patrick R Harrington, Jie Cong, Stephanie B Troy, et al.
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