Results 41 to 50 of about 16,124 (183)
Generative Neural Networks for Addressing the Bioequivalence of Highly Variable Drugs
AlgorithmsBioequivalence assessment of highly variable drugs (HVDs) remains a significant challenge, as the application of scaled approaches requires replicate designs, complex statistical analyses, and varies between regulatory authorities (e.g., FDA and EMA ...
Anastasios Nikolopoulos +1 more
doaj +1 more source
Elaboration of technology and comparative research of pellets of tamsulosin the modified liberation
Бюллетень сибирской медицины, 2011 The work purpose consisted in elaboration of technology of reception pellets of tamsulosin with the modified liberation, and also an estimation of their comparative bioequivalence with a comparison preparation.
Ye. V. Blynskaya +3 more
doaj +1 more source
From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs
Clinical Pharmacology &Therapeutics, EarlyView.New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley +1 more source
Comparative bioequivalence studies of tramadol hydrochloride sustained-release 200 mg tablets
, 2010 Suhas S Khandave1, Satish V Sawant1, Santosh S Joshi1, Yatish K Bansal2, Sonal S Kadam21Accutest Research Laboratories (I) Private Limited, Koparkhirne, Navi Mumbai, Maharashtra, India; 2Ipca Laboratories Limited, Kandivli Mumbai, Maharashtra ...
Khandave Suhas +8 more
core +1 more source
Epileptic Disorders, EarlyView.Abstract Objective Current recommendations for prescribing combined oral contraceptives (COCs) to people with epilepsy are often conflicting, particularly for weak inducers of cytochrome P450 3A4. We aimed to critically review the literature and compare the antiseizure medication (ASM)‐induced changes in exposure to COC components.
Hagar Cohen +4 more
wiley +1 more source
, 2014 4 páginasThis is a pharmacokinetic study of two formulations containing Desvenlafaxine succinate 50 mg extended release. Its objective was to compare the bioavailability between the Test product (Desvenlafaxine ER produced by Tecnoquímicas S.A., Colombia
Villarraga, E., Vargas, M., Vargas, Jba
core +1 more source
Pharmacology Research & Perspectives, 2021 The COVID‐19 pandemic has forced clinical studies to accommodate imposed limitations. In this study, the bioequivalence part could not be conducted as planned.
Dénes Csonka +6 more
doaj +1 more source
Epilepsia, EarlyView.Abstract This article summarizes data for 13 investigational treatments for which at least preliminary seizure outcome data in patients with epilepsy were reported at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices held in Madrid, Spain, on May 3–6, 2026.
Meir Bialer +7 more
wiley +1 more source
Generic drugs: myths, facts, and limitations
Italian Journal of Medicine, 2012 Bioequivalence (BE) has always been an important pharmaceutical area, particularly (but not solely) in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary
Antonio Marzo +2 more
doaj +1 more source
Journal of Pharmacy & Pharmaceutical Sciences, 2020 Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic bioequivalence studies for European/North American generic submissions appeared to have been conducted in geographical/ethnic populations other than those for which the ...
Deniz Ozdin +4 more
doaj +1 more source