Results 61 to 70 of about 9,047 (170)

Pharmacokinetic, Safety, and Immunogenicity Similarity of High‐ and Low‐Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab‐Atto

Pharmacology Research &Perspectives, Volume 14, Issue 2, April 2026.
Consistent with previously demonstrated similarity of biosimilar ABP 501 (adalimumab‐atto) with adalimumab reference product, this study in healthy adults demonstrates the pharmacokinetic, safety, and immunogenicity similarity of a high‐concentration formulation (100 mg/mL) of ABP 501 with the original 50mg/mL formulation.
Vincent Chow, Muhan Zhou, Daniel T. Mytych, Alexander Colbert, Mieke Jill Miller, Iwona Wala, Ahad Sabet, Waldemar Radziszewski   +7 more
wiley   +1 more source

A phase 1 study of berzosertib (M6620, VX‐970) in combination with cisplatin and radiation in patients with locally advanced head and neck squamous cell carcinoma (ETCTN 9950)

Cancer, Volume 132, Issue 6, 15 March 2026.
ABSTRACT Background Ataxia telangiectasia Rad3‐related (ATR) protein kinase regulates DNA damage response and is essential for tumor cell survival. Preclinically, ATR inhibition can sensitize tumor cells to radiation and chemotherapy. The authors conducted a phase 1 trial of berzosertib, a selective ATR inhibitor, in combination with definitive ...
Aarti Bhatia, Zhengjia Chen, Yuji Zhang, Justine Yang Bruce, Susanne Arnold, Varinder Kaur, Jonathan W. Riess, Moon Fenton, Barbara Burtness, Nabil F. Saba, Harold Tara, Conor E. Steuer, Dong M. Shin, Garrett Wasp, Thomas H. Davis, Malini Patel, John C. Schmitz, Priyanka Bhateja, Virginia Diavolitsis, Dan P. Zandberg, Darrion L. Mitchell, Brian F. Kiesel, Charles Kunos, Steven D. Gore, Michael Carducci, Jan H. Beumer, Taofeek K. Owonikoko   +26 more
wiley   +1 more source

Ayurvedic herbal formulations Haridra Khanda and Manjisthadi Kwath (brihat) in the management of allergic rhinitis: A pharmacological study

Heliyon
This study aims to pharmacologically validate Haridra Khanda (HK) and Manjishthadi Kwatham (brihat) (MMK) in allergy management using invivo and invitro studies to rationalize the prescription of these two ayurvedic polyherbal drug formulations, which ...
Rudranil Bhowmik, Md Adil Shaharyar, Mahibub Mahamadsa Kanakal, Arnab Sarkar, Syeda Ayesha Farhana, Shalam M. Hussain, Abdullah Khan, Pallab Mandal, S. Roshan, Achintya Mitra, Sanmoy Karmakar   +10 more
doaj   +1 more source

Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs

BMC Pharmacology and Toxicology, 2017
Background The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale.
Muhammad M. Hammami, Sophia J. S. De Padua, Rajaa Hussein, Eman Al Gaai, Nesrine A. Khodr, Reem Al-Swayeh, Syed N. Alvi, Nada Binhashim   +7 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

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

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

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 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

Population Pharmacokinetic Modeling Practice of Time‐Varying Clearance: Insights from a First‐in‐Human Study Case

The Journal of Clinical Pharmacology, Volume 66, Issue 3, March 2026.
Abstract Accurate characterization of time‐varying clearance (CL) is critical during early drug development, as it informs clinical study design and dosing strategies for future trials. However, detecting and modeling time‐varying clearance is challenging due to limited data availability in early clinical development.
Yongjun Hu, Lan Gao, Ronald Kong
wiley   +1 more source