Results 101 to 110 of about 16,124 (183)

Highly variable medicines - specific aspects of bioequivalence studies

Регуляторные исследования и экспертиза лекарственных средств, 2018
At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic ...
D. P. Romodanovsky, T. V. Eremenkova, M. A. Dranitsyna, D. V. Goryachev, R. R. Niyazov, E. V. Gavrishina, V. A. Merkulov   +6 more
doaj  

Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects

, 2012
Raymond R Tjandrawinata,1 Effi Setiawati,2 Danang Agung Yunaidi,2 Iwan Dwi Santoso,2 Arini Setiawati,3 Liana W Susanto11Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, Indonesia; 2Bioavailability and Bioequivalence Laboratory, Equilab ...
Tjandrawinata RR, Yunaidi DA, Susanto LW, Santoso ID, Setiawati E, Setiawati A   +5 more
core  

Bioavailability and Bioequivalence Studies for Chinese Medicines: Challenge and Opportunity

, 2013
Advanced discussions of the current issues and analyzing the novel approaches of bioavailability & bioequivalence Advanced analytical technologies have provided approaches in analyzing the bioactivities of single component drugs, while the complexity of ...
Feng, Y
core  

Factor VIII in vitro bioequivalence of denecimig (Mim8) hemostatic effect by thrombin generation assays

Research and Practice in Thrombosis and Haemostasis
Background: Denecimig (Mim8, Novo Nordisk A/S) is a next-generation bispecific antibody designed to mimic activated factor (F)VIII and restore hemostasis in persons with hemophilia A.
Jacob Lund, Mirella Ezban, Kasper Jensen, David Lillicrap   +3 more
doaj   +1 more source

Bioequivalence assessment: a pharmaceutical industry perspective.

, 1996
Various aspects of bioequivalence are investigated in this paper. Some aspects dealing with bioequivalence studies conducted either during the development of the drug or after its marketing will be presented and discussed: Bioequivalence of highly ...
Cardot, J M, Lecaillon, J B, Godbillon, J, Lefevre, Gilbert, Sioufi, A   +4 more
core  

Assessing bioequivalence using genomic data

, 2010
[[abstract]]For approval of a generic drug product, the assessment of bioequivalence in drug absorption is usually considered as a surrogate for evaluation of drug efficacy and safety in clinical studies.
Chow, S;Shao, J;Li, L
core   +1 more source

Optimal confidence sets for testing average bioequivalence

Average bioequivalence, Confidence set, Effective length, Multivariate bioequivalence testing, Optimal bioequivalence test, 62F03, 62F25,
Yu-Ling Tseng
core   +1 more source

Problems of bioanalytical part of bioequivalence studies of drugs in Russia

Фармакокинетика и Фармакодинамика, 2014
In the review of the main problems holding bioanalytical part of bioequivalence studies of medicines in Russia. The analysis of the major causes of failure when performing studies of bioequivalence and pharmacokinetics.
A. L. Khokhlov, E. G. Lileeva, O. A. Sinitsyna, S. A. Speshilova, S. M. Demarina, L. N. Shitov   +5 more
doaj  

Bioequivalence Study of Two Formulations of Ibuprofen Arginine Granules in Healthy Chinese Adult Subjects. [PDF]

Drug Des Devel Ther
Xu M, Chen Y, Zhou X, Feng J, Wang Y, Zeng P, Armogida M, Gupta UC, Liu H, Franks B, Jiang Y, Lu T, Yang X, He W.   +13 more
europepmc   +1 more source

Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing. [PDF]

Pharmaceutics
Liu M, Wang Z, Chen Y, Jia Y, Xu L, Xu H, Li J, Zhao L.   +7 more
europepmc   +1 more source