The importance of tracking “missing” metabolites: how and why?
Technologies currently employed to find and identify drug metabolites in complex biological
matrices generally yield results that offer a comprehensive picture of the drug metabolite …
matrices generally yield results that offer a comprehensive picture of the drug metabolite …
Endeavours made by trade associations, pharmaceutical companies and regulators in the replacement, reduction and refinement of animal experimentation in safety …
AW Harrell, K Reid, J Vahle, F Brouta… - Regulatory Toxicology …, 2024 - Elsevier
Abstract Following the European Commission decision to develop a roadmap to phase out
animal testing and the signing of the US Modernisation Act, there is additional pressure on …
animal testing and the signing of the US Modernisation Act, there is additional pressure on …
Non‐labeled, stable labeled, or Radiolabelled approaches for provision of intravenous pharmacokinetics in humans: a discussion piece
GC Young, DK Spracklin, AD James… - Clinical …, 2024 - Wiley Online Library
A review of the use of microdoses and isotopic microtracers for clinical intravenous
pharmacokinetic (iv PK) data provision is presented. The extent of application of the varied …
pharmacokinetic (iv PK) data provision is presented. The extent of application of the varied …
Alpibectir: early qualitative and quantitative metabolic profiling from a first-time-in-human study by combining 19F-NMR (nuclear magnetic resonance), 1H-NMR, and …
DJ Weston, S Thomas, GW Boyle, M Pieren - Drug Metabolism and …, 2024 - Elsevier
Alpibectir (also known as BVL-GSK098 and GSK3729098) is a new chemical entity (NCE)
with a novel mechanism for the treatment of tuberculosis. The disposition of alpibectir was …
with a novel mechanism for the treatment of tuberculosis. The disposition of alpibectir was …
A general perspective for the conduct of radiolabelled distribution, metabolism, and excretion studies for antibody-drug conjugates
B Rudolph, JA Davis, D Hainzl, M Walles - Xenobiotica, 2024 - Taylor & Francis
Antibody-drug conjugates (ADCs) are a class of biopharmaceuticals that combine the
specificity of monoclonal antibodies (mAbs) with the cytotoxicity of small molecule drugs. 15 …
specificity of monoclonal antibodies (mAbs) with the cytotoxicity of small molecule drugs. 15 …
Metabolite bioanalysis in drug development: recommendations from the IQ consortium metabolite bioanalysis working group
W Li, F Vazvaei‐Smith, G Dear, J Boer… - Clinical …, 2024 - Wiley Online Library
The intent of this perspective is to share the recommendations of the International
Consortium for Innovation and Quality in Pharmaceutical Development Metabolite …
Consortium for Innovation and Quality in Pharmaceutical Development Metabolite …
A MIST conception: what has been learned from twenty years of human metabolite safety assessment?
D Luffer-Atlas, RS Obach, DA Smith - Medicinal Chemistry Research, 2023 - Springer
In this review, we trace origins of the joint initiative of the pharmaceutical industry and major
regulatory authorities to provide a framework for the identification, quantification, and testing …
regulatory authorities to provide a framework for the identification, quantification, and testing …
[HTML][HTML] In vitro and in vivo pharmacokinetics, disposition, and drug-drug interaction potential of tinengotinib (TT-00420), a promising investigational drug for treatment …
S Ni, L Li, X Sun, Y Wang, Q Yu, W Wang, Z Gu… - European Journal of …, 2024 - Elsevier
Early-stage clinical evaluation of tinengotinib (TT-00420) demonstrated encouraging
preliminary efficacies in multiple types of refractory cancers, including fibroblast growth …
preliminary efficacies in multiple types of refractory cancers, including fibroblast growth …
Metabolite analysis of 14C-labeled chloromethylisothiazolinone/methylisothiazolinone for toxicological consideration of inhaled isothiazolinone biocides in lungs
Chloro-2-methyl-4-isothiazolin-3-one (CMIT) and 2-methyl-4-isothiazolin-3-one (MIT) used
as preservatives in various products, including humidifier disinfectants, presents substantial …
as preservatives in various products, including humidifier disinfectants, presents substantial …
Small molecule drug metabolite synthesis and identification: why, when and how?
J Shanu-Wilson, S Coe, L Evans, J Steele… - Drug Discovery …, 2024 - Elsevier
The drug discovery and development process encompasses the interrogation of metabolites
arising from the biotransformation of drugs. Here we look at why, when and how metabolites …
arising from the biotransformation of drugs. Here we look at why, when and how metabolites …