Results 61 to 70 of about 9,364 (186)

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects

BMC Medical Research Methodology
Background This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
Turki A. Althunian, Bader R. Alzenaidy, Raseel A. Alroba, Ohoud A. Almadani, Fahad A. Alqahtani, Albatool A. Binajlan, Amal I. Almousa, Deema K. Alamr, Malak S. Al-Mofada, Nora Y. Alsaqer, Hessa A. Alarfaj, Abdulmohsen A. Bahlewa, Mohammed A. Alharbi, Ali M. Alhomaidan, Abdulaziz A. Alsuwyeh, Abdulmohsen A. Alsaleh   +15 more
doaj   +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

An encounter between metal ions and natural products: natural products-coordinated metal ions for the diagnosis and treatment of tumors

Journal of Nanobiotechnology
Natural products-coordinated metal ions to form the nanomedicines are in the spotlight for cancer therapy. Some natural products could be coordinated with metal ions forming nanomedicines via simple and green environmental self-assembly, which not only ...
Xinyue Liu, Suyi Liu, Xingyue Jin, Haifan Liu, Kunhui Sun, Xiongqin Wang, Meifang Li, Ping Wang, Yanxu Chang, Tiejie Wang, Bing Wang, Xie-an Yu   +11 more
doaj   +1 more source

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

A Phase 1 Study to Assess the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate‐Release Tablet in Healthy Adults

Clinical Pharmacology in Drug Development, Volume 15, Issue 6, June 2026.
Abstract Brigatinib is an ALK tyrosine kinase inhibitor approved for the treatment of adults with ALK+ non‐small cell lung cancer. The commercial formulation of brigatinib is an immediate‐release (IR) tablet; however, an oral solution was developed for use in pediatric studies for patients unable to swallow solid oral dosage forms. This randomized, two‐
Michael J. Hanley, Ronald Gounden, Bradley Hupf, Saurabh Sarkar, Robert J. Fram, Neeraj Gupta   +5 more
wiley   +1 more source

Effects of gut microbiota dysbiosis on the metabolism and pharmacokinetics of losartan in rats: from endogenous to ceftriaxone-induced dysbiosis

Frontiers in Microbiology
IntroductionGut microbiota plays a key role in drug metabolism. While gut microbiota dysbiosis is known to contribute to hypertension pathogenesis, its impact on drug metabolism remains poorly considered.
Jiaxuan Xia, Jiaxuan Xia, Jiaxuan Xia, Yibao Jin, Yanjun Hong, Yuefeng Zhang, Meifang Li, Houshuang Huang, Xu Cai, Dan Li, Bing Wang, Zhiyong Xie   +11 more
doaj   +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

Pharmacokinetic Drug–Drug Interaction Potential of Oral Anticancer Drugs

Clinical Pharmacology &Therapeutics, Volume 119, Issue 6, Page 1614-1627, June 2026.
Drug–drug interaction (DDI) management is critical for safe and effective use of oral anticancer drugs (OADs). Our study objectives were to (i) compile clinically relevant pharmacokinetic (PK) DDI mechanisms for OADs and (ii) assess the prevalence of PK potential DDIs (PDDIs) in patients with advanced solid cancers.
Fatimah Alhurayri, Islam R. Younis, Shadia I. Jalal, Theodore F. Logan, Rohan Maniar, Steven M. Bray, Sara K. Quinney, Zeruesenay Desta, Todd C. Skaar, James E. Tisdale, Tyler Shugg   +10 more
wiley   +1 more source

A Comparative Pharmacokinetics Study of the Anti-Parkinsonian Drug Pramipexole

Scientia Pharmaceutica, 2016
The present study aimed to compare pharmacokinetic parameters of two pramipexole 0.25 mg formulations in order to show bioequivalence. The study was conducted in a randomized, open-label, two-period, two-sequence, and crossover design, involving 23 ...
Ratih S. I. Putri, Effi Setiawati, Syifa A. Aziswan, Fenny Ong, Raymond R. Tjandrawinata, Liana W. Susanto   +5 more
doaj   +1 more source