Results 1 to 10 of about 16,124 (183)

Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

Journal of Pharmacy & Pharmaceutical Sciences, 2017
The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January ...
Paramjeet Kaur, Xiaojian Jiang, Ethan Stier   +2 more
doaj   +1 more source

The ability to predict the results of bioequivalence studies based on a consistent statistical analysis of informative factors

Качественная клиническая практика, 2020
Predicting the results of bioequivalence studies is an urgent and important task in developing protocols for clinical studies of bioequivalence. Objective: to develop an algorithm for predicting bioequivalence results based on factors with a sufficient ...
Dmitry P Romodanovsky, Alexandr L Khokhlov   +1 more
doaj   +1 more source

Bioequivalence studies in Morocco

The Pan African Medical Journal, 2020
The development of the generic drug represents one of the strongest axes of the regulation of drug expenditure. In addition to saving the cost of the medical treatment that it allows, it has other interests.
Sanaa Zaoui, Wafaa Fadili
doaj   +1 more source

A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules

Pharmaceutics, 2023
Background: Temozolomide (TMZ) oral suspension (Ped-TMZ, KIZFIZO®) is being developed for the treatment of relapsed or refractory neuroblastoma, a rare cancer affecting infants and young children.
François Ducray, Carole Ramirez, Marie Robert, Maxime Fontanilles, Charlotte Bronnimann, Olivier Chinot, Florian Estrade, Xavier Durando, Stéphanie Cartalat, Jeremy Bastid, Hugues Bienayme, Caroline Lemarchand   +11 more
doaj   +1 more source

Pharmacokinetic profile of phenytoin in dried blood spot with high-performance liquid chromatography—photodiode array

Frontiers in Pharmacology
Phenytoin is a first-line antiepileptic drug with narrow therapeutic range and follows non-linear pharmacokinetics. Pharmacokinetics of phenytoin have been studied in plasma matrix before, however, there were several disadvantages.
Yahdiana Harahap, Yahdiana Harahap, Limeylia Ng, Sunarsih Sunarsih   +3 more
doaj   +1 more source

Pharmacokinetic Simulation and Area under the Curve Estimation of Drugs Subject to Enterohepatic Circulation

Pharmaceutics
Enterohepatic circulation (EHC) is a complex process where drugs undergo secretion and reabsorption from the intestinal lumen multiple times, resulting in pharmacokinetic profiles with multiple peaks.
Melchor Alpízar, José de Jesús Reséndiz, Elisa García Martínez, Sanyog Dwivedi, Miguel Alejandro Trejo   +4 more
doaj   +1 more source

Predictive Potential of C_max Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ₂ Similarity Factor Method

Pharmaceutics, 2023
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally ...
Sara Carolina Henriques, Paulo Paixão, Luis Almeida, Nuno Elvas Silva   +3 more
doaj   +1 more source

Toward Predictable Nanomedicine: Current Forecasting Frameworks for Nanoparticle–Biology Interactions

Advanced Intelligent Discovery, EarlyView.
Predictive models successfully screen nanoparticles for toxicity and cellular uptake. Yet, complex biological dynamics and sparse, nonstandardized data limit their accuracy. The field urgently needs integrated artificial intelligence/machine learning, systems biology, and open‐access data protocols to bridge the gap between materials science and safe ...
Mariya L. Ivanova, Michael Nicholls, Nicola Russo, Gueorgui Mihaylov, Konstantin Nikolic   +4 more
wiley   +1 more source

Autonomous AI‐Driven Design for Skin Product Formulations

Advanced Intelligent Discovery, EarlyView.
This review presents a comprehensive closed‐loop framework for autonomous skin product formulation design. By integrating artificial intelligence‐driven experiment selection with automated multi‐tiered assays, the approach shifts development from trial‐and‐error to intelligent optimisation.
Yu Zhang, Yongrui Xiao, Chunlin Chen, Dimitrios Tsaoulidis, Kai Yang, Tao Chen   +5 more
wiley   +1 more source

MicroRNA: unveiling novel mechanistic and theranostic pathways in diabetic cardiomyopathy

Frontiers in Pharmacology
Diabetic cardiomyopathy (DCM) is a prominent contributor to morbidity and mortality in people with diabetes worldwide. In diabetic patients, it is a chronic condition that is characterized by ventricular hypertrophy (VH), diastolic dysfunction ...
Akash De, Arnab Sarkar, Tanmoy Banerjee, Rudranil Bhowmik, Shuvam Sar, Md. Adil Shaharyar, Sanmoy Karmakar, Nilanjan Ghosh   +7 more
doaj   +1 more source