Results 61 to 70 of about 26,646 (226)

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, Elisabetta Porro, Anna Barassi   +2 more
doaj   +1 more source

Pharmacokinetics of Bexagliflozin After Intravenous and Oral Administration in Cats

Journal of Veterinary Pharmacology and Therapeutics, EarlyView.
ABSTRACT Bexagliflozin, a selective sodium–glucose cotransporter 2 (SGLT2) inhibitor, has been developed for feline diabetes mellitus. This study characterized bexagliflozin pharmacokinetics in healthy cats after single intravenous and oral administrations.
Yogini Patel, Sheeva Bhattarai, Céline E. Toutain   +2 more
wiley   +1 more source

Effect of truncating AUC at 12, 24 and 48 hr when evaluating the bioequivalence of drugs with a Long Half-Life [PDF]

, 2016
This is the peer reviewed version of the following article: Basic an Clinical Pharmacology and Toxicology 118.1 (2016): 53-7 which has been published in final form at http://dx.doi.org/10.1111/bcpt.12432.
Abad Santos, Francisco, Cabaleiro, Teresa, Moreno, Isabel, Ochoa, Dolores, Román, Manuel   +4 more
core   +2 more sources

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

PLoS ONE, 2019
BackgroundAffordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with ...
Warren A Kaplan, Jorge Cárdenas, Cristián Mansilla, Tatiana Tobar, Veronika J Wirtz   +4 more
doaj   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Plasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration. [PDF]

, 2020
OBJECTIVE: To evaluate the pharmacokinetics of tranexamic acid after oral administration to postpartum women. METHODS: We conducted a single-center pharmacokinetic study at Teaching Hospital-Jaffna, Sri Lanka, on 12 healthy postpartum women who delivered
Arulkumaran, S, Balakumar, S, Muhunthan, K, Navaratnaraja, TS, Premakrishna, S   +4 more
core   +1 more source

Low‐intervention clinical trials in Spain: Do they progress?

British Journal of Clinical Pharmacology, Volume 92, Issue 5, Page 1438-1444, May 2026.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza, Mayro J. Cortés Pestana, Kristopher Amaro, Rosa M. Antonijoan, Caridad Pontes   +4 more
wiley   +1 more source

Influence of Different Populations on Pharmacokinetic Bioequivalence Results: Can We Extrapolate Bioequivalence Results from One Population to Another?

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, Murray P. Ducharme, France Varin, Anders Fuglsang, Dina Al-Numani   +4 more
doaj   +1 more source

Hypnotic doses of fazamorexant induced less impairment on balance and cognition than zolpidem in healthy younger and elderly individuals

British Journal of Clinical Pharmacology, Volume 92, Issue 5, Page 1473-1486, May 2026.
Aims Fazamorexant is a dual orexin receptor antagonist being developed for the treatment of insomnia. This study aims to determine the dose‐exposure‐response relationship of single‐dose fazamorexant vs. zolpidem in young adult and elderly healthy Chinese volunteers. Methods This single‐centre, randomized, double‐blind, double‐dummy, placebo‐ and active‐
Chen Xia, Huang Xingxing, Jin Lu, Wang Ruwei   +3 more
wiley   +1 more source

Nanocarriers based therapy and diagnosis of brain diseases: cross the blood-brain barrier

Science and Technology of Advanced Materials
The blood-brain barrier (BBB) is the protective interface that isolates the central nervous system from circulating blood, which restricts approximately 98% of small molecule drugs and nearly all large molecules from entering the brain.
Lijun An, Jinwei Zhang, Xiaobo Wang, Yuanyuan Ge, Kunhui Sun, Junlin Dong, Ping Wang, Wei Li, Meifang Li, Xuelei Hu, Bing Wang, Xie-An Yu   +11 more
doaj   +1 more source