Results 51 to 60 of about 396 (132)

A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies

open access: yesClinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1350-1361, May 2026.
Regional differences in approved drug dosages and administration are shaped by complex factors, including clinical data, prior regulatory decisions, and region‐specific considerations. This study investigated how such factors are associated with variations in approved doses across the United States Food and Drug Administration (FDA), European Medicines
Sachiko Mita, Shunsuke Ono
wiley   +1 more source

Annual Banned‐Substance Review 18th Edition—Analytical Approaches in Human Sports Drug Testing 2024/2025

open access: yesDrug Testing and Analysis, Volume 18, Issue 4, Page 458-482, April 2026.
New insights into drug metabolism, distribution, elimination, and detection assays for drugs and methods of sports doping published between 2024 and 2025 are critically reviewed and evaluated in context with the Prohibited List 2025 as established by the World Anti‐Doping Agency.
Mario Thevis, Tiia Kuuranne, Hans Geyer
wiley   +1 more source

Artificial lipidation of proteins and peptides: from mechanism to clinical applications

open access: yesThe FEBS Journal, Volume 293, Issue 5, Page 1269-1284, March 2026.
Artificial lipidation transforms protein and peptide therapeutics by attaching fatty acid chains through reversible or permanent chemical strategies. This biomimetic approach delivers four key therapeutic advantages: extended circulation times (enabling weekly instead of daily dosing), alternative administration routes including oral delivery, precise ...
Jiaming Mu, Emily Vong, Sheiliza Carmali
wiley   +1 more source

Long-acting growth hormone for treating growth hormone deficiency in children: a meta-analysis of randomized controlled trials focusing on changes in body mass index.

open access: yesJ Clin Endocrinol Metab
International audienceAbstract Backgound The purpose of this study is to compare the effect of long-acting growth hormone (LAGH) to daily GH on body mass index (BMI) in children with growth hormone deficiency (GHD).
Levaillant L   +11 more
europepmc   +2 more sources

Strategies to Improve the Lipophilicity of Hydrophilic Macromolecular Drugs

open access: yesAdvanced Healthcare Materials, Volume 15, Issue 5, 2 February 2026.
Hydrophilic macromolecular drugs can be successfully lipidized by covalent attachment of lipids, by hydrophobic ion pairing with negatively or positively charged surfactants, and by dry or wet reverse micelle formation. Lipophilicity enhancement of hydrophilic macromolecules has several benefits including stability and bioavailability improvement ...
Sera Lindner   +8 more
wiley   +1 more source

Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study

open access: yesEuropean Journal of Endocrinology
Abstract Objective Daily growth hormone (GH) injections restore normal growth and improve psychological outcomes in children with idiopathic short stature (ISS) but treatment burden is significant.
Jennifer Abuzzahab   +7 more
openaire   +2 more sources

Annual Banned‐Substance Review 17th Edition—Analytical Approaches in Human Sports Drug Testing 2023/2024

open access: yesDrug Testing and Analysis, Volume 17, Issue 8, Page 1417-1442, August 2025.
Scenarios of drug exposure and administration as well as detection assays for drugs and methods of sports doping published between 2023 and 2024 are critically reviewed and evaluated in context with the Prohibited List 2024 as established by the World Anti‐Doping Agency.
Mario  Thevis   +2 more
wiley   +1 more source

Escherichia coli in the production of biopharmaceuticals

open access: yesBiotechnology and Applied Biochemistry, Volume 72, Issue 2, Page 528-541, April 2025.
Abstract Escherichia coli has shouldered a massive workload with the discovery of recombinant DNA technology. A new era began in the biopharmaceutical industry with the production of insulin, the first recombinant protein, in E. coli and its use in treating diabetes. After insulin, many biopharmaceuticals produced from E. coli have been approved by the
İbrahim İncir, Özlem Kaplan
wiley   +1 more source

A Phase 2 Study of PEGylated Recombinant Human Growth Hormone for 52 Weeks in Short Children Born Small for Gestational Age in China

open access: yesClinical Endocrinology, Volume 102, Issue 2, Page 136-146, February 2025.
ABSTRACT Objective Children born small for gestational age (SGA) are at increased risk of health issues. This study evaluated the efficacy, safety and optimal dose of PEGylated‐recombinant human growth hormone (PEG‐rhGH) in these children. Design In this multicentre, randomised, open‐label, Phase 2 trial conducted at nine clinical sites in China ...
Xiaoping Luo   +17 more
wiley   +1 more source

New Insights Into Hepatic Impairment (HI) Trials

open access: yesClinical and Translational Science, Volume 18, Issue 1, January 2025.
ABSTRACT Hepatic impairment (HI) trials are traditionally part of the clinical pharmacology development to assess the need for dose adaptation in people with impaired metabolic capacity due to their diseased liver. This review aimed at looking into the data from dedicated HI studies, cluster these data into various categories and connect the effect by ...
Sebastian Haertter   +4 more
wiley   +1 more source

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