Advances on Clinical Pharmacokinetics towards Drug Selection in Pregnant Women

[摘要] Over the last decade, analytical technology and methodologies for Drug Metabolism and Pharmacokinetics (DMPK) research in thepharmaceutical industry and academic research organisations have progressed fast. On the one hand, small molecule drug candidates requirean earlier and better knowledge of their Absorption, Distribution, Metabolism, and Excretion (ADME) in humans, as well as theirinteractions with metabolising enzymes, transporters, and therapeutic targets such as receptors and DNA. On the other hand, various noveldrug modalities and delivery systems have been brought into the drug pipeline, including peptide and protein therapies, Antibody-DrugConjugates (ADC), and nano drug delivery systems. Their bioanalysis and ADME examination in vitro and in vivo provide significantobstacles, necessitating the employment of analytical methods and methodologies that may differ significantly from those often utilised inDMPK investigations of small compounds. This special issue of the Journal of Pharmaceutical Analysis focuses on recently developedanalytical technologies and methods for improving the efficiency and quality of ADME studies in support of traditional drug discoveryprogrammes or for investigating the metabolism and disposition of new drug modalities and delivery systems. Cancer and pregnancy cooccurring is an uncommon clinical scenario (1/1000 pregnancies), with breast cancer being the most common solid tumour in pregnantindividuals. Recent clinical data suggest that systemic treatment in breast cancer patients during the second and third trimesters of pregnancyshould be as close to that used in non-pregnant patients as possible (level of evidence 2b), with the exception of trastuzumab, which hasrenal toxicity for the foetus due to significant trans placental transfer.

[学科分类] 药理学