Results 51 to 60 of about 396 (132)
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
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
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
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
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
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
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
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
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
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

