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pro vyhledávání: '"Andre J. Jackson"'
Autor:
Andre J. Jackson, Henry C. Foehl
Publikováno v:
The AAPS Journal. 24
Publikováno v:
PLoS ONE, Vol 9, Iss 9, p e108392 (2014)
The objective of this study was to develop and explore new, in silico experimental methods for deciphering complex, highly variable absorption and food interaction pharmacokinetics observed for a modified-release drug product. Toward that aim, we con
Externí odkaz:
https://doaj.org/article/bdfc24e23376434facd2ccc3e025c376
Autor:
Andre J. Jackson
Publikováno v:
Journal of Bioequivalence & Bioavailability. 11
To determine if a literature-sourced physiological model for immediate-release (IR) methylphenidate (MPH), with addition of parameters for extended-release (ER) absorption can be adapted for NONMEM analysis to describe extended-release MPH drug produ
Autor:
Andre J. Jackson
Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Pr
Publikováno v:
Annals of Pharmacotherapy. 48:306-313
Background: More than 50 % of individuals affected by adverse drug events (ADEs) are older adults. Establishing a drug dosing regimen that balances benefit and risk, and minimizes ADEs in older populations can be challenging. Objective: The aim of th
Publikováno v:
Journal of Pharmaceutical Sciences. 101:4337-4346
A simulation study was done to determine if 72 h is the most informative sampling duration for bioequivalence (BE) determination in paralleldesigned BE studies with drugs that have half-lives of at least 30 h. The impact of absorption and elimination
Autor:
Jing Zhang, Mitchell V. Mathis, Hiren D. Patel, Hao Zhu, Peiling Yang, Andre J. Jackson, George Kordzakhia, Linda Fossom, Jenn W. Sellers, Robert Temple, Ellis F. Unger, Antonia Dow
Publikováno v:
The Journal of clinical psychiatry. 76(1)
Objective This article summarizes the US Food and Drug Administration's (FDA's) review of the New Drug Application for vortioxetine, especially the clinical efficacy and safety data. It emphasizes the issues that were important to the FDA's approval
Autor:
Andre J. Jackson
Publikováno v:
Biopharmaceutics & Drug Disposition. 22:179-190
The usefulness of a limited sampling method (LSM) to determine the bioequivalence of highly variable drugs with long half-lives was investigated. The LSM uses multiple linear regression of observed drug plasma concentrations versus area under the cur
Publikováno v:
Biopharmaceutics & Drug Disposition. 21:139-146
In bioequivalence studies, the first blood or plasma sample taken after dosing sometimes yields a higher assayed drug concentration than any samples drawn thereafter. This circumstance ('first C(max)' or 'FCM'), is usually considered undesirable, sin
Autor:
Andre J. Jackson
Publikováno v:
Pharmaceutical Research. 17:1432-1436
Purpose. Simulated pharmacokinetic (PK) studies were done to determine the effect of intrinsic clearance (CLINT) on the probability of meeting bioequivalence criteria for extent (AUC) and rate (Cmax) of drug absorption when the absorption rate and fr