Results 81 to 90 of about 16,124 (183)

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

Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications

Clinical and Translational Science, Volume 19, Issue 10, October 2026.
ABSTRACT To advance drug product development, regulatory decision making, and improve patient care, FDA has committed to the quantitative medicine paradigm that involves, among others, quantitative in silico methodologies and tools developed based on nonclinical, clinical, and real‐world sources. In this Perspective, Model Master File (MMF) submissions
Eleftheria Tsakalozou, Rachel Erdman, Lei Zhang, Robert Lionberger, Lanyan Fang   +4 more
wiley   +1 more source

Review Article - Bioequivalence: Issues and perspectives [PDF]

, 2007
The design, performance and evaluation of bioavailability and bioequivalence have evolved over the last two decades. Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bioavailability of a test product and ...
Rani, Shubha
core   +2 more sources

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 New Highly Concentrated Insulin Aspart AT278 (500 U/mL) Demonstrates Ultra‐Rapid Pharmacokinetic and Pharmacodynamic Properties in Type 2 Diabetes Regardless of BMI

Diabetes, Obesity and Metabolism, Volume 28, Issue 10, Page 9423-9432, October 2026.
ABSTRACT Aims To evaluate the pharmacokinetics, pharmacodynamics, and safety of a novel U500 insulin aspart formulation (AT278 [500 U/mL]; AT278‐U500) compared with standard concentration insulin aspart (InsAsp [100 U/mL]; InsAsp‐U100) and U500 human regular insulin (HumIns [500 IU/mL]; HumIns‐U500). Materials and Methods This single‐centre, randomised,
Eva Svehlikova, Christina Gatschelhofer, Bettina Lackner, Maria Ratzer, Gabriele Fluhr, Anja Stoisser, Gregor Kolaric, David Gerring, Sarah Howell, Jan Jezek, Fiona Lawrence, Thomas R. Pieber   +11 more
wiley   +1 more source

Ayurvedic herbal formulations Haridra Khanda and Manjisthadi Kwath (brihat) in the management of allergic rhinitis: A pharmacological study

Heliyon
This study aims to pharmacologically validate Haridra Khanda (HK) and Manjishthadi Kwatham (brihat) (MMK) in allergy management using invivo and invitro studies to rationalize the prescription of these two ayurvedic polyherbal drug formulations, which ...
Rudranil Bhowmik, Md Adil Shaharyar, Mahibub Mahamadsa Kanakal, Arnab Sarkar, Syeda Ayesha Farhana, Shalam M. Hussain, Abdullah Khan, Pallab Mandal, S. Roshan, Achintya Mitra, Sanmoy Karmakar   +10 more
doaj   +1 more source

Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians

, 2015
4 páginasThis is a pharmacokinetic study of two formulations containing Rosuvastatin 40 mg, with the aim to compare the Bioavailability between the Test product (Rosuvastatin made by Laboratorios Tecnoquímicas S.A., Colombia) and the Reference product ...
Bustamante C., Vargas M., Villarraga E.
core   +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