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Clinical Pharmacology and Therapeutics
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November 25, 2020
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence
Jieon Lee, Yuqing Gong, Sid Bhoopathy, et al.
Journal of Medicinal Chemistry
|
April 2, 2005
Syntheses and biological activities of rebeccamycin analogues with uncommon sugars
Guisheng Zhang, Jie Shen, Hao Cheng, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
April 12, 2022
Quantitative methods and modeling to assess COVID-19-interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches
Yuqing Gong, Kairui Feng, Peijue Zhang, et al.
Eclinicalmedicine
|
September 29, 2021
Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance
Liang Zhao, Zhichuan Li, Lanyan Fang, et al.
The AAPS Journal
|
October 30, 2020
New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling
Florence Loingeville, Julie Bertrand, Thu Thuy Nguyen, et al.
Pharmaceutical Research
|
July 15, 2006
Why is it challenging to predict intestinal drug absorption and oral bioavailability in human using rat model
Xianhua Cao, Seth T Gibbs, Lanyan Fang, et al.
Journal of Pharmacokinetics and Pharmacodynamics
|
September 16, 2022
Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies
Mélanie Guhl, François Mercier, Carsten Hofmann, et al.
Clinical Pharmacology and Therapeutics
|
November 12, 2024
Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations
Mark Donnelly, Lanyan Fang, Rajanikanth Madabushi, et al.
Clinical Pharmacology and Therapeutics
|
January 18, 2025
A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments
Robert Hopefl, Yuqing Gong, Elizabeth Bielski, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
January 11, 2023
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview
Andrew Babiskin, Fang Wu, Youssef Mousa, et al.
Page
of 7
Search research articles
Search
Showing results (51-60 of 70) with videos related to
Sort By:
Page
of 7
Clinical Pharmacology and Therapeutics
|
November 25, 2020
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence
Jieon Lee, Yuqing Gong, Sid Bhoopathy, et al.
Journal of Medicinal Chemistry
|
April 2, 2005
Syntheses and biological activities of rebeccamycin analogues with uncommon sugars
Guisheng Zhang, Jie Shen, Hao Cheng, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
April 12, 2022
Quantitative methods and modeling to assess COVID-19-interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches
Yuqing Gong, Kairui Feng, Peijue Zhang, et al.
Eclinicalmedicine
|
September 29, 2021
Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance
Liang Zhao, Zhichuan Li, Lanyan Fang, et al.
The AAPS Journal
|
October 30, 2020
New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling
Florence Loingeville, Julie Bertrand, Thu Thuy Nguyen, et al.
Pharmaceutical Research
|
July 15, 2006
Why is it challenging to predict intestinal drug absorption and oral bioavailability in human using rat model
Xianhua Cao, Seth T Gibbs, Lanyan Fang, et al.
Journal of Pharmacokinetics and Pharmacodynamics
|
September 16, 2022
Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies
Mélanie Guhl, François Mercier, Carsten Hofmann, et al.
Clinical Pharmacology and Therapeutics
|
November 12, 2024
Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations
Mark Donnelly, Lanyan Fang, Rajanikanth Madabushi, et al.
Clinical Pharmacology and Therapeutics
|
January 18, 2025
A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments
Robert Hopefl, Yuqing Gong, Elizabeth Bielski, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
January 11, 2023
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview
Andrew Babiskin, Fang Wu, Youssef Mousa, et al.
Page
of 7