Results 41 to 50 of about 9,371 (163)

Bioequivalence studies for levothyroxine [PDF]

The AAPS Journal, 2005
The Food and Drug Administration (FDA) Guidance for Bioavailability and Bioequivalence Studies for Levothyroxine has been challenged by companies that manufacture brand-name products. Their contention is that the current guidance does not adequately address the endogenous background levels of the drug, and that the ratios of the PK parameters, a basis ...
openaire   +2 more sources

Effects of gut microbiota dysbiosis on the metabolism and pharmacokinetics of losartan in rats: from endogenous to ceftriaxone-induced dysbiosis

Frontiers in Microbiology
IntroductionGut microbiota plays a key role in drug metabolism. While gut microbiota dysbiosis is known to contribute to hypertension pathogenesis, its impact on drug metabolism remains poorly considered.
Jiaxuan Xia, Jiaxuan Xia, Jiaxuan Xia, Yibao Jin, Yanjun Hong, Yuefeng Zhang, Meifang Li, Houshuang Huang, Xu Cai, Dan Li, Bing Wang, Zhiyong Xie   +11 more
doaj   +1 more source

A Comparative Pharmacokinetics Study of the Anti-Parkinsonian Drug Pramipexole

Scientia Pharmaceutica, 2016
The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 ...
Ratih S. I. Putri, Effi Setiawati, Syifa A. Aziswan, Fenny Ong, Raymond R. Tjandrawinata, Liana W. Susanto   +5 more
doaj   +1 more source

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects

Acta Pharmaceutica Sinica B, 2016
The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male ...
Fang Tang, Rui Zhou, Zeneng Cheng, Guoping Yang, Aiqiao Chen, Zhi Liu, Hongyi Tan, Shuang Yang, Sanwang Li, Lingli Mu, Peng Yu   +10 more
doaj   +1 more source

A single-dose, randomized, open-label, four-period, crossover equivalence trial comparing the clinical similarity of the proposed biosimilar rupatadine fumarate to reference Wystamm® in healthy Chinese subjects

Frontiers in Pharmacology
PurposeThe aim of this study was to evaluate the bioequivalence of two formulations of rupatadine (10-mg tablets) under fasting and fed conditions in healthy Chinese subjects.MethodsA total of 72 subjects were randomly assigned to the fasting cohort (n =
Sisi Lin, Yutao Lou, Rui Hao, Yiming Shao, Jin Yu, Lu Fang, Meihua Bao, Wu Yi, Yiwen Zhang, Yiwen Zhang, Yiwen Zhang   +10 more
doaj   +1 more source

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

Clinical and Translational Science, 2019
In this paper, a special case for bioequivalence evaluation of oral formulations is discussed. Drug formulations with different forms of active moieties (e.g., free base and salt) may yield different dissolution characteristics and, thus, differ in ...
Hao Zhu, Xiaomei Chen, Mariam Ahmed, Yaning Wang, Qi Liu, Ramana S. Uppoor, Colleen Kuemmel, Mehul Mehta   +7 more
doaj   +1 more source

From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus^®-Driven Framework for Generic Candesartan Cilexetil Tablets

Pharmaceuticals
Background: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first ...
Hao Ruan, Xiaoting Geng, Zijing Situ, Qian Shen, Tianjian Ye, Xin Chen, Weike Su   +6 more
doaj   +1 more source

Comparison of tape stripping with the human skin blanching assay for the bioequivalence assessment of topical clobetasol propionate formulations.

Journal of Pharmacy & Pharmaceutical Sciences, 2010
Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn.
Wai Ling Au, Michael F Skinner, Isadore Kanfer   +2 more
doaj   +1 more source

Planning and evaluation of bioequivalence studies of rosuvastatin drug products

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation.
D. P. Romodanovsky, D. V. Goryachev
doaj