Results 1 to 10 of about 9,314 (141)

Bioequivalence of a Fixed-Dose Combination of Relugolix, Estradiol, and Norethindrone Acetate: An Open-Label, Randomized, Fully Replicate Crossover Study in Healthy Postmenopausal Women Under Fasting Conditions. [PDF]

Clin Pharmacol Drug Dev
Abstract Uterine fibroids are the most common benign gynecological tumors, often causing heavy menstrual bleeding (HMB), anemia, and impaired quality of life. A fixed‐dose combination (FDC) of relugolix (40 mg), estradiol (1 mg), and norethindrone acetate (0.5 mg) was developed to address these limitations.
Kotadia R, Kumar S, Khuroo A, Dharmadhikari S, Shahi P, Narayana GNVSS, Reyar S.   +6 more
europepmc   +2 more sources

Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight. [PDF]

Diabetes Obes Metab
ABSTRACT Aims To evaluate the bioequivalence of orally administered orforglipron tablets and capsules in participants with obesity or overweight who were otherwise healthy. Materials and Methods This phase 1, multicenter, open‐label, multiple‐dose, dose‐escalation study was conducted in 429 healthy adults.
Ma X, Li YG, Raha S, Sperry DC, Coutant DE, Bhattachar S.   +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

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

Is a Clinical Trial With a Non-Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK. [PDF]

Clin Pharmacol Ther
Although physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Dong J, Moir A, Pepin X, Lowe E, Hopkins S, Tang W, Zhou D.   +6 more
europepmc   +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

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