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Stella Grosser

Showing results (11-20 of 23) with videos related to

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Pharmaceutical Statistics|August 9, 2023
Adaptive designs for IVPT data with mixed scaled average bioequivalenceDaeyoung Lim, Elena Rantou, Jessica Kim, et al.
Therapeutic Innovation & Regulatory Science|October 27, 2018
Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality MetricsJason Woo, Jingyu Julia Luan, Zili Li, et al.
Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America|June 13, 2002
Validity of self-reporting of episodes of external genital wartsD J Wiley, Stella Grosser, Karen Qi, et al.
Pharmaceutical Research|October 31, 2025
A Proposal for Alternative FDA Bioequivalence Criteria for Narrow Therapeutic Index Drug Products to Support Future HarmonizationWanjie Sun, Donald Schuirmann, Fairouz Makhlouf, et al.
Statistics in Medicine|June 7, 2024
Model-based bioequivalence approach for sparse pharmacokinetic bioequivalence studies: Model selection or model averaging?Morgane Philipp, Adrien Tessier, Mark Donnelly, et al.
Pharmaceutical Research|March 7, 2025
Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting ReportEleftheria Tsakalozou, Lanyan Fang, Erin Skoda, et al.
CPT: Pharmacometrics & Systems Pharmacology|April 28, 2023
Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studiesCoralie Tardivon, Florence Loingeville, Mark Donnelly, et al.
Biostatistics (Oxford, England)|July 23, 2020
Efficient model-based bioequivalence testingKathrin Möllenhoff, Florence Loingeville, Julie Bertrand, et al.
The AAPS Journal|February 27, 2024
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDALanyan Fang, Yuqing Gong, Andrew C Hooker, et al.
Statistical Methods in Medical Research|July 14, 2025
Model-based approach for two-stage group sequential or adaptive designs in bioequivalence studies using parallel and crossover designsFlorence Loingeville, Manel Rakez, Thu Thuy Nguyen, et al.
Pageof 3

Showing results (11-20 of 23) with videos related to

Sort By:
Pageof 3
Pharmaceutical Statistics|August 9, 2023
Adaptive designs for IVPT data with mixed scaled average bioequivalenceDaeyoung Lim, Elena Rantou, Jessica Kim, et al.
Therapeutic Innovation & Regulatory Science|October 27, 2018
Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality MetricsJason Woo, Jingyu Julia Luan, Zili Li, et al.
Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America|June 13, 2002
Validity of self-reporting of episodes of external genital wartsD J Wiley, Stella Grosser, Karen Qi, et al.
Pharmaceutical Research|October 31, 2025
A Proposal for Alternative FDA Bioequivalence Criteria for Narrow Therapeutic Index Drug Products to Support Future HarmonizationWanjie Sun, Donald Schuirmann, Fairouz Makhlouf, et al.
Statistics in Medicine|June 7, 2024
Model-based bioequivalence approach for sparse pharmacokinetic bioequivalence studies: Model selection or model averaging?Morgane Philipp, Adrien Tessier, Mark Donnelly, et al.
Pharmaceutical Research|March 7, 2025
Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting ReportEleftheria Tsakalozou, Lanyan Fang, Erin Skoda, et al.
CPT: Pharmacometrics & Systems Pharmacology|April 28, 2023
Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studiesCoralie Tardivon, Florence Loingeville, Mark Donnelly, et al.
Biostatistics (Oxford, England)|July 23, 2020
Efficient model-based bioequivalence testingKathrin Möllenhoff, Florence Loingeville, Julie Bertrand, et al.
The AAPS Journal|February 27, 2024
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDALanyan Fang, Yuqing Gong, Andrew C Hooker, et al.
Statistical Methods in Medical Research|July 14, 2025
Model-based approach for two-stage group sequential or adaptive designs in bioequivalence studies using parallel and crossover designsFlorence Loingeville, Manel Rakez, Thu Thuy Nguyen, et al.
Pageof 3