Results 11 to 20 of about 9,047 (170)

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

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

Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed-Dose Combination Tablets in Healthy Chinese Volunteers. [PDF]

Clin Pharmacol Drug Dev
Abstract This single‐center, randomized, open‐label bioequivalence program compared two fixed‐dose combination (FDC) tablets containing ibuprofen (200 mg) and phenylephrine hydrochloride (10 mg) from different manufacturers in healthy Chinese adults under fasting and fed conditions. A three‐period, partially replicated crossover design was used for the
Ye M, Zhang R, Wan J, Zhou J, Guo P, Yu D, Li P, Liu Y, Shi S.   +8 more
europepmc   +2 more sources

Application in silico Modeling Simulation in Bioequivalence Studies: A Review

Journal of Food and Pharmaceutical Sciences, 2023
Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies ...
Sekar Ayu Pawestri
doaj   +1 more source

Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies

Drugs in R&D, 2023
Background and Objectives Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development.
Dejan Krajcar, Rebeka Jereb, Igor Legen, Jerneja Opara, Iztok Grabnar   +4 more
doaj   +1 more source