Results 11 to 20 of about 9,371 (163)

Indicators of Evidence for Bioequivalence [PDF]

Entropy, 2016
Some equivalence tests are based on two one-sided tests, where in many applications the test statistics are approximately normal. We define and find evidence for equivalence in Z-tests and then one- and two-sample binomial tests as well as for t-tests. Multivariate equivalence tests are typically based on statistics with non-central chi-squared or non ...
Stephan Morgenthaler, Robert G. Staudte
openaire   +2 more sources

Relevant Issues of Planning Bioequivalence Studies of Drugs with a Narrow Therapeutic Range

Регуляторные исследования и экспертиза лекарственных средств, 2020
In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivalence or therapeutic equivalence studies. In most cases, comparative pharmacokinetic studies and demonstration of bioequivalence between the test and the ...
D. P. Romodanovsky
doaj   +1 more source

Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical‐driven balance of population average and variability

CPT: Pharmacometrics & Systems Pharmacology, 2022
Among the current approaches for the analysis of bioequivalence, the average bioequivalence (ABE) is limited only to the mean bioavailability, whereas the population bioequivalence (PBE) criterion aggregates both mean and variance in a general comparison
Sara Soufsaf, Fahima Nekka, Jun Li
doaj   +1 more source

PRINCIPLES OF STATISTICAL EVALUATION OF BIOEQUIVALENCE STUDIES IN THE CONTEXT OF CURRENT REGULATORY REQUIREMENTS AND LEGAL ACTS

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article analyses regulatory documents and requirements for statistical principles of planning and evaluation of results of bioequivalence studies. It describes current statistical approaches to bioequivalence evaluation and relevant recommendations ...
D. P. Romodanovsky, D. V. Goryachev, A. P. Solovieva, N. N. Eremenko   +3 more
doaj   +1 more source

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

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

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

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