Zobrazeno 1 - 10
of 73
pro vyhledávání: '"Lanyan Fang"'
Autor:
Xiaomei Chen, Henrik B. Nyberg, Mark Donnelly, Liang Zhao, Lanyan Fang, Mats O. Karlsson, Andrew C. Hooker
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 10, Pp 1734-1747 (2024)
Abstract By applying nonlinear mixed‐effect (NLME) models, model‐integrated evidence (MIE) approaches are able to analyze bioequivalence (BE) data with pharmacokinetic end points that have sparse sampling, which is problematic for non‐compartme
Externí odkaz:
https://doaj.org/article/2e1329167ac44ce096430f86304bb58d
Autor:
Henrik Bjugård Nyberg, Xiaomei Chen, Mark Donnelly, Lanyan Fang, Liang Zhao, Mats O. Karlsson, Andrew C. Hooker
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 10, Pp 1748-1761 (2024)
Abstract Conventional approaches for establishing bioequivalence (BE) between test and reference formulations using non‐compartmental analysis (NCA) may demonstrate low power in pharmacokinetic (PK) studies with sparse sampling. In this case, model
Externí odkaz:
https://doaj.org/article/818524a9727b4db99705ea0d5a2a6947
Autor:
Ming‐Liang Tan, Zongming Gao, Andrew Babiskin, Myong‐Jin Kim, Lanyan Fang, Lei Zhang, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 2, Pp 247-256 (2024)
Abstract Proton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating the gastric pH. Our recent clinical study has demonstrated that drug–drug interactions (DDIs) exist between a PPI, omeprazole, and n
Externí odkaz:
https://doaj.org/article/7ace8b2458c443dda103dac182085770
Autor:
Coralie Tardivon, Florence Loingeville, Mark Donnelly, Kairui Feng, Wanjie Sun, Guoying Sun, Stella Grosser, Liang Zhao, Lanyan Fang, France Mentré, Julie Bertrand
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 7, Pp 904-915 (2023)
Abstract In a traditional pharmacokinetic (PK) bioequivalence (BE) study, a two‐way crossover study is conducted, PK parameters (namely the area under the time‐concentration curve [AUC] and the maximal concentration [Cmax]) are obtained by noncom
Externí odkaz:
https://doaj.org/article/139a16dd116f45258f338771f7006e43
Autor:
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 624-630 (2023)
Abstract On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrat
Externí odkaz:
https://doaj.org/article/7ba25868225a4671a0706b3a2c4392e8
Autor:
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming‐Liang Tan, Eleftheria Tsakalozou, Ross L. Walenga, Miyoung Yoon, Sam G. Raney, James E. Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 619-623 (2023)
Abstract On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bi
Externí odkaz:
https://doaj.org/article/44b240479fc442e095e071b1478a7197
Autor:
Eleftheria Tsakalozou, Khondoker Alam, Priyanka Ghosh, Jessica Spires, Sebastian Polak, Lanyan Fang, Srinivasa Sammeta, Ping Zhao, Sumit Arora, Sam G. Raney
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 575-584 (2023)
Abstract The development of a generic drug product involves demonstrating that there is no significant difference in the rate and extent to which the active ingredient becomes available at the site of action, relative to the reference listed drug pro
Externí odkaz:
https://doaj.org/article/a95d06aa883441cea4bb45e8923b51a2
Autor:
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 585-597 (2023)
Abstract This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the
Externí odkaz:
https://doaj.org/article/bff355b182e94d38a6b888911c0d4a2e
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 552-555 (2023)
Externí odkaz:
https://doaj.org/article/818aecd9dc364a1bbd1d8a96989f7924
Autor:
Abdullah Al Shoyaib, Arian Emami Riedmaier, Anita Kumar, Partha Roy, Neil John Parrott, Lanyan Fang, Nilufer Tampal, Yuching Yang, Rebeka Jereb, Liang Zhao, Fang Wu
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 610-618 (2023)
Abstract This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop title
Externí odkaz:
https://doaj.org/article/fc0a03feb23a426592eb8c8e2923117e