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Design and Process Considerations for Preparation of Modified Release Ivermectin and Praziquantel Tablets by Wet Granulation.
AAPS PharmSciTech
January 2025
University of Maryland, School of Pharmacy, Department of Pharmaceutical Sciences, 20 N Pine Street, Baltimore, Maryland, 21201, USA.
Dosage forms containing Ivermectin (IVER) and Praziquantel (PRAZ) are important combination drug products in animal health. Understanding the relationship between products with differing in vitro release characteristics and bioequivalence could facilitate generics. The goal of this study was to create granulations for each active ingredient, with similar release mechanisms, but substantially different in vitro release rates, and then compressing these granulations into tablets with differing release rates.
View Article and Find Full Text PDFA multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer.
J Cancer Res Clin Oncol
January 2025
Phase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Purpose: The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast cancer.
Methods: To achieve these goals, the trial employed a randomized, open-label, two-formulation crossover dosing strategy among Chinese patients with metastatic breast cancer. Pharmacokinetic (PK) evaluation was conducted through the collection of blood samples, and the liquid chromatography tandem mass spectrometry (LC/MS/MS) method was leveraged to quantify plasma concentrations of both liposome-encapsulated doxorubicin and non-encapsulated doxorubicin in patients.
Pharmacokinetics and bioequivalence evaluation of two oral formulations of topiramate tablets in healthy Chinese male volunteers under fasting and fed conditions.
Naunyn Schmiedebergs Arch Pharmacol
January 2025
Anhui Provincial Center of Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Topiramate is an antiepileptic drug (AED) that is effective in treating various types of epilepsy. This study evaluated the bioequivalence and safety of two topiramate tablets in healthy Chinese subjects under fasting and fed conditions. We designed an open-label, randomized, single-dose, two-period, crossover trial protocol.
View Article and Find Full Text PDFPimobendan oral solution is bioequivalent to pimobendan chewable tablets in beagle dogs.
J Vet Intern Med
January 2025
Boehringer Ingelheim Pharma GmbH & Co., Ingelheim, Germany.
Background: Myxomatous mitral valve disease (MMVD) is frequently diagnosed in small breed dogs. Pimobendan oral solution has been developed to improve dosing accuracy in small and toy breed dogs.
Hypothesis/objectives: Demonstrate bioequivalence of pimobendan oral solution with pimobendan chewable tablets using a pharmacokinetic and a pharmacodynamic study in healthy purpose bred dogs.
Bioequivalence study of fluticasone propionate nebuliser suspensions in healthy Chinese subjects.
Front Pharmacol
January 2025
Phase I Clinical Trial Site, Nanjing Gaoxin Hospital, Nanjing, Jiangsu, China.
Background: Fluticasone propionate is a synthetic trifluoro-substituted glucocorticoid, a highly selective glucocorticoid receptor agonist. Fluticasone propionate nebuliser suspensions is an inhaled corticosteroid with the low systemic bioavailability which provides a low risk (benefit outcome without the adverse effects that accompany systemically administered corticosteroids), referred as a first-line preventive agent for patients with persistent asthma. China has become one of the countries with the highest asthma mortality rate in the world in the past years.
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