Results 71 to 80 of about 9,047 (170)

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

Using PBPK to Simulate Target Biopredictive Dissolution Profiles for Long‐Acting Injectables ‐ Where to Begin With Critical Bioavailability Attributes?

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 3, March 2026.
ABSTRACT Long‐acting injectables (LAI) are of increasing interest as they facilitate improved medication adherence and exposure, with target plasma concentration levels maintained over weeks/months. Biopredictive in vitro dissolution tests can aid formulation development of LAIs and guide quality control dissolution testing by facilitating accelerated ...
Hannah Cleary, Nikoletta Fotaki, Tim Persoons, Deirdre M. D'Arcy   +3 more
wiley   +1 more source

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

Pharmaceuticals
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product. However, bioequivalence studies represent significant complexities due to the interplay of multiple factors related to ...
Sivacharan Kollipara, Frederico Severino Martins, Rebeka Jereb, Dejan Krajcar, Tausif Ahmed   +4 more
doaj   +1 more source

Physiologically Based Pharmacokinetic Virtual Twin Approach for Fludarabine Dosing in Pediatric Hematopoietic Stem Cell Transplantation

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 3, March 2026.
ABSTRACT Fludarabine (Flu), administered as a prodrug Flu monophosphate, is a lymphodepleting agent used prior to hematopoietic stem cell transplantation (HSCT) which exhibits substantial pharmacokinetics (PK) variability, contributing to suboptimal outcomes.
Mourad Mseddi, Christa Nath, Khalil Ben Hassine, Vid Mlakar, Yvonne Gloor, Fanny Gonzales, Chakradhara Rao S. Uppugunduri, Youssef Daali, Steven Keogh, Marc Ansari   +9 more
wiley   +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

Model‐Informed Dosing Regimen of Sugemalimab for European Patients With Non‐Small Cell Lung Cancer: Bridging From Asian Clinical Data

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 3, March 2026.
ABSTRACT Model‐informed drug development (MIDD) framework was employed to bridge sugemalimab dosing from an Asian population to European patients with non‐small cell lung cancer. We evaluated whether a fixed dose of 1200 mg every 3 weeks (Q3W) provides adequate exposure for European patients and, if not, which weight threshold and alternative dose ...
Yucheng Sheng, Zenglian Yue, Fengyan Xu, Kun Wang, Jingru Wang, Qingmei Shi   +5 more
wiley   +1 more source

Population Pharmacokinetic Analysis of Vixarelimab in Healthy Volunteers and Patients With Chronic Pruritic Conditions

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 3, March 2026.
ABSTRACT Vixarelimab is a first‐in‐class fully human monoclonal antibody targeting oncostatin M (OSM) receptor beta (OSMRβ). It has been evaluated in Phase 1 and 2 studies in healthy volunteers and patients with chronic pruritic conditions and demonstrated anti‐pruritic efficacy in a Phase 2 study in prurigo nodularis, but detailed pharmacokinetic ...
Fei Tang, Steve Dang, Audrey Arjomandi, Lin Pan, Joy Hsu, Smita Kshirsagar, Nastya Kassir   +6 more
wiley   +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

Evaluation of Drug–Drug Interaction Potential Between the Oral Antibiotic Zoliflodacin and the CYP3A4 Inhibitor Itraconazole: A Phase 1 Study in Healthy Participants

Clinical and Translational Science, Volume 19, Issue 3, March 2026.
ABSTRACT Zoliflodacin is a first‐in‐class oral spiropyrimidinetrione antibiotic being developed for patients with uncomplicated gonorrhea, including those infected with multidrug‐resistant strains. Because zoliflodacin is metabolized by cytochrome P450 3A4 (CYP3A4), concomitant administration with a CYP3A inhibitor has the potential to increase ...
Alison Luckey, Kajal B. Larson, Noha Rayad, Markus Heep, Sophie Delhomme, Gabrielle Kornmann, John P. Mueller, John P. O'Donnell, Seamus O'Brien, Rainard Fuhr, Jean‐Yves Gillon   +10 more
wiley   +1 more source