Results 41 to 50 of about 4,403,980 (152)

Bioequivalence of narrow therapeutic index drugs and immunosuppressives [PDF]

, 2015
Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies.
Godman, Brian, Baumgärtel, Christoph
core   +3 more sources

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen [PDF]

European Journal of Pharmaceutical Sciences, 2020
Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set clinically relevant specifications.
Loisios-Konstantinidis, Ioannis, Cristofoletti, Rodrigo, Fotaki, Nikoletta, Turner, David B., Dressman, Jennifer   +4 more
openaire   +2 more sources

A Physiologically Based Pharmacokinetic Model for Studying the Biowaiver Risk of Biopharmaceutics Classification System Class I Drugs With Rapid Elimination: Dexketoprofen Trometamol Case Study

Frontiers in Pharmacology, 2022
Biowaiver based on the biopharmaceutics classification system (BCS) has been widely used in the global market for the approval of new generic drug products to avoid unnecessary in vivo bioequivalence (BE) studies.
Xian Zhang, Xuxiao Ye, Kuan Hu, Wenping Li, Wenqian Li, Qingqing Xiao, Lin Chen, Jin Yang   +7 more
doaj   +1 more source

Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study

Clinical and Translational Science, 2023
In vitro‐in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles and can be used to reduce the number of bioequivalence (BE) studies during product development, and ...
Jiaying Wang, Jinliang Chen, Lu Wang, Dandan Yang, Rong Shao, Honggang Lou, Zourong Ruan, Bo Jiang   +7 more
doaj   +1 more source

Non-equivalence of antibiotic generic drugs and risk for intensive care patients [PDF]

, 2013
Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic ...
Reshetnykov, Mykhaylo, Rangoonwala, Ramzan, Ghanaati, Shahram Michael, Kirkpatrick, Charles James, Barbeck, Mike   +4 more
core   +1 more source

A Rational Approach to Predicting Immediate Release Formulation Behavior in Multiple Gastric Motility Patterns: A Combination of a Biorelevant Apparatus, Design of Experiments, and Machine Learning

Pharmaceutics, 2023
Gastric mechanical stress often impacts drug dissolution from solid oral dosage forms, but in vitro experiments cannot recreate the substantial variability of gastric motility in a reasonable time.
Marcela Staniszewska, Michał Romański, Sebastian Polak, Grzegorz Garbacz, Justyna Dobosz, Daria Myslitska, Svitlana Romanova, Jadwiga Paszkowska, Dorota Danielak   +8 more
doaj   +1 more source

Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses. [PDF]

AAPS J
Morris NM, Jamei M, Alam K, Tsakalozou E, Donnelly M, Feng K, Bois FY.   +6 more
europepmc   +2 more sources

Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol

CPT: Pharmacometrics & Systems Pharmacology, 2021
Merck KGaA observed slight differences in the dissolution of Concor® (bisoprolol) batches over the years. The purpose of this work was to assess the impact of in vitro dissolution on the simulated pharmacokinetics of bisoprolol using in vitro–in vivo ...
Joyce S. Macwan, Grace Fraczkiewicz, Mauro Bertolino, Phillip Krüger, Sheila‐Annie Peters   +4 more
doaj   +1 more source

Population Pharmacokinetic Method to Predict Within-Subject Variability Using Single-Period Clinical Data

Pharmaceuticals, 2021
Sample sizes for single-period clinical trials, including pharmacokinetic studies, are statistically determined by within-subject variability (WSV).
Won-ho Kang, Jae-yeon Lee, Jung-woo Chae, Kyeong-Ryoon Lee, In-hwan Baek, Min-Soo Kim, Hyun-moon Back, Sangkeun Jung, Craig Shaffer, Rada Savic, Hwi-yeol Yun   +10 more
doaj   +1 more source

Perception of Complex Emotional Body Language of a Virtual Character [PDF]

, 2012
Virtual characters are a common phenomenon in serious game applications, and can enrich training environments for a range of different purposes. These characters can be used in games that have been developed to help people with learning difficulties ...
Bekris, Kostas, Egges, J., Sub Games & Virtual Worlds begr. 1/9/13, Ennis, C., Games and Virtual Worlds, Kallmann, Marcelo   +5 more
core   +1 more source