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1 . Academic Journal
Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance
저자
by
Zhao, Liang
;
Li, Zhichuan
;
Fang, Lanyan
;
Kim, Myong-Jin
;
Nallani, Srikanth C.
, et al.
소스
In
eClinicalMedicine
November 2021 41
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7 . Academic Journal
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.
저자
by
Pal, Arindom
;
Wu, Fang
;
Walenga, Ross
;
Tsakalozou, Eleftheria
;
Alam, Khondoker
, et al.
소스
AAPS Journal; Jun2024, Vol. 26 Issue 3, p1-7, 7p
Scopus
Web of Science
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7 . Academic Journal
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability.
저자
by
Li, Shuhui
;
Feng, Kairui
;
Lee, Jieon
;
Gong, Yuqing
;
Wu, Fang
, et al.
소스
AAPS Journal; Jun2024, Vol. 26 Issue 3, p1-12, 12p
Scopus
Web of Science
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7 . Academic Journal
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.
저자
by
Fang, Lanyan
;
Gong, Yuqing
;
Hooker, Andrew C.
;
Lukacova, Viera
;
Rostami-Hodjegan, Amin
, et al.
소스
AAPS Journal; Apr2024, Vol. 26 Issue 2, p1-7, 7p
Scopus
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7 . Academic Journal
Use of physiologically‐based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended‐release nifedipine.
저자
by
Tan, Ming‐Liang
;
Gao, Zongming
;
Babiskin, Andrew
;
Kim, Myong‐Jin
;
Fang, Lanyan
, et al.
소스
CPT: Pharmacometrics & Systems Pharmacology
. Feb2024, Vol. 13 Issue 2, p247-256. 10p.
Open Access (Wiley)
Scopus
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7 . Academic Journal
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report.
저자
by
Tsakalozou, Eleftheria
;
Fang, Lanyan
;
Bi, Youwei
;
van den Heuvel, Michiel
;
Ahmed, Tausif
, et al.
소스
AAPS Journal; Feb2024, Vol. 26 Issue 1, p1-8, 8p
Scopus
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7 . Academic Journal
Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.
저자
by
Tsakalozou, Eleftheria
;
Gong, Yuqing
;
Babiskin, Andrew
;
Hu, Meng
;
Mousa, Youssef
, et al.
소스
AAPS Journal; Jun2024, Vol. 26 Issue 3, p1-3, 3p
Scopus
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7 . Academic Journal
Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies.
저자
by
Tardivon, Coralie
;
Loingeville, Florence
;
Donnelly, Mark
;
Feng, Kairui
;
Sun, Wanjie
, et al.
소스
CPT: Pharmacometrics & Systems Pharmacology
. Jul2023, Vol. 12 Issue 7, p904-915. 12p.
Open Access (Wiley)
Scopus
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7 . Academic Journal
Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study.
저자
by
Pawar, Gopal
;
Wu, Fang
;
Zhao, Liang
;
Fang, Lanyan
;
Burckart, Gilbert J.
, et al.
소스
AAPS Journal; Jul2023, Vol. 25 Issue 4, p1-18, 18p
Scopus
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7 . Report
Efficient model-based Bioequivalence Testing
저자
by
Möllenhoff, Kathrin
;
Loingeville, Florence
;
Bertrand, Julie
;
Nguyen, Thu Thuy
;
Sharan, Satish
, et al.
소스
Open Access (Arxiv)
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