Zobrazeno 1 - 10
of 86
pro vyhledávání: '"Andrew C, Hooker"'
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:
Xiaomei Chen, Rikard Nordgren, Stella Belin, Alzahra Hamdan, Shijun Wang, Tianwu Yang, Zhe Huang, Simon J. Carter, Simon Buatois, João A. Abrantes, Andrew C. Hooker, Mats O. Karlsson
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 10, Pp 1784-1797 (2024)
Abstract Population pharmacokinetic (PK) models are widely used to inform drug development by pharmaceutical companies and facilitate drug evaluation by regulatory agencies. Developing a population PK model is a multi‐step, challenging, and time‐
Externí odkaz:
https://doaj.org/article/7b021a7f7b66484a8b7f9eaa81834ea5
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:
Alzahra Hamdan, Andrew C. Hooker, Xiaomei Chen, Andreas Traschütz, Rebecca Schüle, ARCA Study Group, EVIDENCE‐RND consortium, Matthis Synofzik, Mats O. Karlsson
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 8, Pp 1327-1340 (2024)
Abstract The Scale for the Assessment and Rating of Ataxia (SARA) is widely used for assessing the severity and progression of genetic cerebellar ataxias. SARA is now considered a primary end point in several ataxia treatment trials, but its underlyi
Externí odkaz:
https://doaj.org/article/ca2491fc5edd4d2f979817cba54b2637
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 2, Pp 270-280 (2024)
Abstract Pharmacokinetic (PK) studies in children are usually small and have ethical constraints due to the medical complexities of drawing blood in this special population. Often, population PK models for the drug(s) of interest are available in adu
Externí odkaz:
https://doaj.org/article/796e30fcefea4ca38b54e5f8e73f951d
Autor:
Martin Geroldinger, Johan Verbeeck, Andrew C. Hooker, Konstantin E. Thiel, Geert Molenberghs, Joakim Nyberg, Johann Bauer, Martin Laimer, Verena Wally, Arne C. Bathke, Georg Zimmermann
Publikováno v:
Orphanet Journal of Rare Diseases, Vol 18, Iss 1, Pp 1-12 (2023)
Abstract Background Recommendations for statistical methods in rare disease trials are scarce, especially for cross-over designs. As a result various state-of-the-art methodologies were compared as neutrally as possible using an illustrative data set
Externí odkaz:
https://doaj.org/article/4f9b12e7fc3f4ae699a506a509e41b49
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
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 12, Pp 1452-1465 (2021)
Abstract This NONMEM tutorial shows how to evaluate and optimize clinical trial designs, using algorithms developed in design software, such as PopED and PFIM 4.0. Parameter precision and model parameter estimability is obtained by assessing the Fish
Externí odkaz:
https://doaj.org/article/a49bb5cc3d384545ab719dfcdf26765d
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 11, Pp 1297-1309 (2021)
Abstract Metaheuristics is a powerful optimization tool that is increasingly used across disciplines to tackle general purpose optimization problems. Nature‐inspired metaheuristic algorithms is a subclass of metaheuristic algorithms and have been s
Externí odkaz:
https://doaj.org/article/181a5c3d446e45b9be8d279ba200df3d
Autor:
Yevgen Ryeznik, Oleksandr Sverdlov, Elin M. Svensson, Grace Montepiedra, Andrew C. Hooker, Weng Kee Wong
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 10, Pp 1134-1149 (2021)
Abstract Modern drug development problems are very complex and require integration of various scientific fields. Traditionally, statistical methods have been the primary tool for design and analysis of clinical trials. Increasingly, pharmacometric ap
Externí odkaz:
https://doaj.org/article/ed27afe540b74da88001b28b0e29afc4