Results 21 to 30 of about 16,124 (183)

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

open access: yesCPT: 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

Non-equivalence of antibiotic generic drugs and risk for intensive care patients [PDF]

open access: yes, 2013
Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic ...
Reshetnykov, Mykhaylo   +4 more
core   +1 more source

Bioequivalence of losartan/amlodipine fixed dose combination tablets (losanet AM) compared with concomitant administration of Single components of losartan and amlodipine tablets in healthy human volunteers [PDF]

open access: yes, 2017
A fixed dose combination of losartan, an angiotensin receptor blocker and amlodipine, a calcium channel blocker, can potentially provide complementary mechanism of action to improve blood pressure control and clinical outcomes.
Daccache, Elie   +7 more
core   +1 more source

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

open access: yesРегуляторные 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   +3 more
doaj   +1 more source

Pharmacokinetic studies for the development of transdermal drug delivery systems [PDF]

open access: yes, 2007
PhDThis thesis mainly describes a series of Phase I pharmacokinetic studies conducted on the TDS®d elivery systemw hich combinedw ith lidocaine,t estosteronea, nd a new drug, Melanotan-I for the transdermal drug delivery.
Chik, Zamri
core   +4 more sources

600 mg Oxcarbazepine Tablets Bioequivalence Study

open access: yes, 2017
4 páginasBioequivalence studies are evidence of generic drugs quality, demonstrating that the rate and quantity of effective substance absorbed from each of the studied formulations, showed no significant differences. The aim of the pharmacokinetic study
Vargas, M., Villarraga, EA
core   +1 more source

Bioequivalence Study of Two Formulations That Contain Isotretinoin 20 mg Capsules in Healthy Colombian Volunteers

open access: yes, 2016
4 páginasThis is a pharmacokinetic test of two formulations that contain 20 mg of Isotretinoin, with the aim to compare the bioavailability between the Test Product (Isoface® from Procaps Laboratory SA, Colombia) and the Reference Product (Roaccutane ...
Batista M.   +4 more
core   +1 more source

Drug Bioequivalence [PDF]

open access: yes, 1974
Report of the findings from a panel of the Office of Technology Assessment (OTA) regarding drug bioequivalence therapies. According to the report, the purpose of the Drug Bioequivalence Study Panel "was to examine the relationships between the chemical ...
United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel.
core  

Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers

open access: yes, 2016
4 páginasThis is a pharmacokinetic study of two formulations containing Lurasidone 80 mg, with the aim to compare the Bioavailability between the Test product (Lurasidone made by Laboratorios Lafrancol S.A, Colombia) and the Reference product (Latuda ...
Vargas M., Villarraga EA
core   +1 more source

A Comparison of Pharmacokinetics of two Tablet Formulations Containing Artemether / Lumefantrine – Quality Criteria for Malaria Treatment Assurance [PDF]

open access: yes, 2012
\ud Treatment of non-severe malaria remains a challenge to endemic areas including Tanzania. Since November 2006, Coartem® an artemisinin based combination therapy (ACT) containing artemether-lumefantrine (ALu), replaced sulphadoxine/pyrimethamine (SP ...
Alphonce, Ignace
core  

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