Results 21 to 30 of about 32,756 (214)

Effect of enzalutamide on anticoagulant therapy with edoxaban in patients with prostate cancer

British Journal of Clinical Pharmacology, EarlyView.
Aims Treatment with enzalutamide in prostate cancer is challenging due to its high potential for drug–drug interactions, particularly in the typically older population of patients with frequent comorbidities treated with multiple drugs, such as anticoagulants.
Catharina J. P. Op 't Hoog, Niven Mehra, Anouk van Kleef, Diederik M. Somford, Inge M. van Oort, Alex L. T. Imholz, Paul Hamberg, Nielka P. van Erp, Emmy Boerrigter   +8 more
wiley   +1 more source

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

British Journal of Clinical Pharmacology, EarlyView.
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

Assessing the similarity of dose response and target doses in two non-overlapping subgroups [PDF]

, 2017
We consider two problems that are attracting increasing attention in clinical dose finding studies. First, we assess the similarity of two non-linear regression models for two non-overlapping subgroups of patients over a restricted covariate space.
Bretz, Frank, Dette, Holger, Liu, Wei, Möllenhoff, Kathrin, Trampisch, Matthias   +4 more
core   +2 more sources

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

British Journal of Clinical Pharmacology, EarlyView.
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

Can biorelevant media be simplified by using SLS and tween 80 to replace bile compounds? [PDF]

, 2013
In the scientific literature, the use of a surfactant is recommended for both designing quality control tests for water insoluble or sparingly water soluble drugs and for predicting the bioavailability of drugs from various types of formulations.
Klein, Sandra, Taupitz, Thomas
core  

A theoretical framework for estimation of AUCs in complete and incomplete sampling designs. [PDF]

, 2009
Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in humans. The drug exposure in animal studies is often measured by the area under the concentration versus time curve (AUC)
Jaki, Thomas, Wolfsegger, Martin J.
core   +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

A multipart phase 1 study of the safety, pharmacodynamics and pharmacokinetics of ALG‐055009, a novel thyroid hormone receptor beta (THR‐β) agonist for metabolic dysfunction‐associated steatohepatitis (MASH), in healthy participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract ALG–055009 is an oral thyroid hormone receptor beta (THR‐β) agonist being evaluated for treating metabolic dysfunction–associated steatohepatitis (MASH). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALG‐055009 and bioavailability/food effect.
Hakim Charfi, Benedetta Massetto, Megan Fitzgerald, Kha Le, Stanley Wang, Ifong Kan‐Eng, Meenakshi Venkatraman, Naqvi Mohammad, Lawrence Blatt, Tse‐I Lin, Sushmita M. Chanda, John Fry   +11 more
wiley   +1 more source

An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review [PDF]

, 2007
This paper provides a detailed example of how one should write the statistical section of a bioequivalence study protocol for FDA review. Three forms of bioequivalence are covered: average bioequivalence (ABE), population bioequivalence (PBE) and ...
McCarthy, William F.
core   +1 more source

Rupture Test and Bioavailability of Oil-Soluble Vitamins [PDF]

, 2013
In lieu of an abstract, here is the article\u27s first paragraph: Bioavailability of multi-vitamins as dietary supplements has always been a concern. Dissolution studies have been successfully used to predict drug release of bioactive molecules, but with
Chablani, Lipika
core   +2 more sources