Results 1 to 10 of about 26,646 (226)

A Novel Ultra-Performance Liquid Chromatography-Electrospray Ionisation-Tandem Mass Spectrometry Method for Quantification of Imeglimin in Human Plasma: Application to a Bioequivalence Study. [PDF]

Anal Sci Adv
ABSTRACT The pharmaceutical market has recently witnessed the advent of a novel tetrahydrotriazene molecule belonging to the new pharmacological class “Glimins”, named Imeglimin (IMG). It has been approved in Japan as a safe and highly effective oral diabetic drug for type II diabetic patients.
Wadie M, Badr KA, Hosny AA, Logoyda L, Sebai OME, Rezk MR.   +5 more
europepmc   +2 more sources

Bioequivalence centres in Africa: current state and opportunities for growth [PDF]

Journal of Pharmaceutical Policy and Practice
Bioequivalence studies are required for generic medicines to meet the same quality, safety, and efficacy standards as innovator products before receiving marketing authorisation. These studies compare the in vivo performance of a generic medicine to that
Bakani Mark Ncube, Sarah Muthuri, Olawale Ajose, Loice Kikwai   +3 more
doaj   +2 more sources

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

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   +2 more sources

Accelerating Generic Long-Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access. [PDF]

Clin Pharmacol Ther
The global HIV response aims for widespread availability of affordable, quality‐assured long‐acting antiretroviral (LA ARV) drugs to achieve sustained epidemic control, particularly in low‐ and middle‐income countries. This report summarizes key discussion points, findings, and outcomes from an international workshop on generic LA ARVs, held in ...
Arshad U, Gaayeb L, Pertinez H, Rajoli RKR, Watkins M, Nimbolkar P, Perazzolo S, Pagi B, Wensing A, Khoo S, Boffito M, Holm R, Panos Z, Mahaka I, Venter F, Kottiri B, Crawford KW, Ho RJY, Clayden P, Domanico P, Struble K, Owen A, Flexner C.   +22 more
europepmc   +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   +3 more sources

Development and validation of a UPLC-MS/MS method with volumetric absorptive microsampling to quantitate cyclophosphamide and 4-hydroxycyclophosphamide

Frontiers in Pharmacology, 2022
Cyclophosphamide (CP) is an anti-cancer alkylating prodrug, metabolized by CYP450 into its active metabolite 4-hydroxycyclophosphamide (4-OHCP). Its therapeutic effectiveness is determined by the 4-OHCP concentration. Several analytical methods in plasma
Yahdiana Harahap, Yahdiana Harahap, Steven Steven, Herman Suryadi   +3 more
doaj   +1 more source

Determination of O6-Methylguanine in dried blood spot of breast cancer patients after cyclophosphamide administration

Heliyon, 2021
Cyclophosphamide is a nitrogen mustard class of drugs that are often used in cancer chemotherapy. However, the use of Cyclophosphamide in high doses over a long period has been shown to increase the risk of developing secondary cancer.
Yahdiana Harahap, Athalia Theda Tanujaya, Farhan Nurahman, Aurelia Maria Vianney, Denni Joko Purwanto   +4 more
doaj   +1 more source

Bioequivalence data analysis [PDF]

Translational and Clinical Pharmacology, 2020
SAS® is commonly used for bioequivalence (BE) data analysis. R is a free and open software for general purpose data analysis, and is less frequently used than SAS® for BE data analysis. This tutorial explains how R can be used for BE data analysis to generate comparable results with SAS®.
Gowooni Park, Hyungsub Kim, Kyun-Seop Bae   +2 more
openaire   +2 more sources

Vaccine Formulation Strategies and Challenges Involved in RNA Delivery for Modulating Biomarkers of Cardiovascular Diseases: A Race from Laboratory to Market

Vaccines, 2023
It has been demonstrated that noncoding RNAs have significant physiological and pathological roles. Modulation of noncoding RNAs may offer therapeutic approaches as per recent findings. Small RNAs, mostly long noncoding RNAs, siRNA, and microRNAs make up
Md. Adil Shaharyar, Rudranil Bhowmik, Fahad A. Al-Abbasi, Shareefa A. AlGhamdi, Amira M. Alghamdi, Arnab Sarkar, Imran Kazmi, Sanmoy Karmakar   +7 more
doaj   +1 more source

Methylphenidate Multiphasic Release Tablet: Bioequivalence Assessment between Two Formulations Administered under Fasting and Fed Conditions

Pharmaceutics, 2023
Methylphenidate hydrochloride is used to treat children, adolescents, and adults with attention deficit/hyperactivity disorder (ADHD). Multiphasic release formulation has been used to control drug levels, mainly during children’s school period.
Marcelo Gomes Davanço, Jessica Meulman, Thalita Martins da Silva, Fernando Costa, Karini Bruno Bellorio, Iram Moreira Mundim, Ana Carolina Costa Sampaio, Leonardo de Souza Teixeira, Celso Francisco Pimentel Vespasiano   +8 more
doaj   +1 more source