Results 81 to 90 of about 26,646 (226)

The Current Use and Future Perspectives of Biosimilars in Pediatric Healthcare: A Narrative Review

Health Science Reports, Volume 9, Issue 5, May 2026.
ABSTRACT Background and Aims The integration of biosimilars into pediatric healthcare represents a significant evolution in treatment accessibility and cost‐effectiveness. Biosimilars—biological products highly similar to already approved biologics, have emerged as promising alternatives for managing chronic and rare pediatric conditions, including ...
Zubaier Ahmed, Tasfiah Tasnim Maha, Sanjana Nowsher, Wasima Taslim, Fatema‐Tuz‐Zohora, Sabrina Sharmin, Hasina Yasmin   +6 more
wiley   +1 more source

Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method [PDF]

, 2015
Background: Montelukast (MT) is a leukotriene D4 antagonist. It is an effective and safe medicine for the prophylaxis and treatment of chronic asthma. It is also used to prevent acute exercise-induced bronchoconstriction and as a symptomatic relief of ...
Abualhasan, Murad N, Bustami, Rana, Ghazal, Nadia, Mousa, Ayman, Watson, David G, Zaid, Abdel Naser   +5 more
core   +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

Evaluation of Relative Bioavailability and Food Effect of a Fixed‐Dose Combination Tablet of Islatravir and Lenacapavir

The Journal of Clinical Pharmacology, Volume 66, Issue 5, May 2026.
Abstract Long‐acting oral HIV‐1 treatments can potentially reduce pill burden, treatment fatigue, suboptimal adherence, and treatment failure. A combination of islatravir, a nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a capsid inhibitor, is being investigated as a weekly oral HIV‐1 treatment.
Jing Niu, Haeyoung Zhang, John Ling, Sharline Madera, Nerissa Kwok, Steve West, Diane Longo, Gillian Gillespie, Cyril Llamoso, Dhananjay D. Marathe   +9 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

Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability

Journal of Probability and Statistics, 2015
For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study.
Jianghao Li, Shein-Chung Chow
doaj   +1 more source

Development of a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified‐Release Tablets

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 5, May 2026.
ABSTRACT Predictive in vitro dissolution methods are crucial for anticipating in vivo drug performance, particularly for poorly soluble drugs like carbamazepine. In vitro‐in vivo correlations (IVIVC) link dissolution characteristics to pharmacokinetics, facilitating bioequivalence studies and reducing reliance on clinical trials.
Laura Carvajal Barbosa, Sandra Milena Echeverry, Diana Marcela Aragón   +2 more
wiley   +1 more source

Testing for equivalence: an intersection-union permutation solution

, 2018
The notion of testing for equivalence of two treatments is widely used in clinical trials, pharmaceutical experiments,bioequivalence and quality control. It is essentially approached within the intersection-union (IU) principle.
Arboretti, R., Carrozzo, E., Pesarin, F., Salmaso, L.   +3 more
core   +1 more source

Comparison of Bioavailability Between the Most Available Generic Tablet Formulation Containing Artemether and Lumefantrine on the Tanzanian Market and the Innovator's Product. [PDF]

, 2013
Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa has raised a concern on patients achieving therapeutic concentrations after intake of these products.
AA Amin, AM Dondorp, AM Dondorp, AO Toure, D Menard, Eliford Ngaimisi, GR Wilkinson, Ignace A Marealle, J Mwesiga, LK Basco, M Kongthaisong, MA van Agtmael, Mastidia Rutaihwa, Mwajuma Chemba, MY Zeng, NJ White, O Shakoor, OM Minzi, OM Minzi, Omar Juma, Omary MS Minzi, Philip Sasi, R Bate, RN Price, S Yeung, Salim Abdulla, Seif Shekalaghe, T Uno, US Food and Drug Administration, US Food and Drug Administration, V Keoluangkhot   +30 more
core   +2 more sources

Population Pharmacokinetic Modeling and Exposure‐Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 5, May 2026.
ABSTRACT Nemtabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor under clinical investigation in patients with hematologic malignancies, including chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL). Nemtabrutinib plasma concentration data from 578 patients enrolled in phase 1 and 2 clinical studies, treated with doses from 5 to ...
Chiara C. Kemal, Thijs J. Zweers, Elke H. J. Krekels, Manash S. Chatterjee   +3 more
wiley   +1 more source