Publications by authors named "V P Purohit"
Article Synopsis
- - Ritlecitinib is an oral medication being developed for treating moderate-to-severe alopecia areata, functioning as an irreversible inhibitor of specific kinases.
- - A study using advanced mass spectroscopy explored how ritlecitinib is absorbed, distributed, metabolized, and eliminated in the body, revealing key pharmacokinetic parameters like a clearance rate of 43.7 L/h and a bioavailability of 64%.
- - The research found that ritlecitinib binds to plasma proteins and is mainly cleared through urine, with metabolic processes involving various cytochrome P450 enzymes and glutathione-related conjugation playing significant roles.
studies of formulation performance with and/or simulations are often limited by significant gaps in our knowledge of the interaction between administered dosage forms and the human gastrointestinal tract. This work presents a novel approach for the investigation of gastric motility influence on dosage form performance, by combining biopredictive dissolution tests in an innovative apparatus with mechanistic physiology-based pharmacokinetic modeling. The methodology was based on the pharmacokinetic data from a large ( = 118) cohort of healthy volunteers who ingested a capsule containing a highly soluble and rapidly absorbed drug under fasted conditions.
View Article and Find Full Text PDFThe recruitment of a parallel, healthy participants (HPs) arm in renal and hepatic impairment (RI and HI) studies is a common strategy to assess differences in pharmacokinetics. Limitations in this approach include the underpowered estimate of exposure differences and the use of the drug in a population for which there is no benefit. Recently, a method was published by Purohit et.
View Article and Find Full Text PDFArticle Synopsis
- * To gain regulatory approval for the MR microsphere, researchers needed to establish bioequivalence (BE) with the IR solution, which was achieved by conducting physiologically-based pharmacokinetic (PBPK) virtual BE trials instead of traditional clinical ones.
- * The trials showed that the MR microsphere (10 mg once daily) is bioequivalent to the IR solution (5 mg twice daily) after both a single and multiple doses, highlighting a new method that minimizes unnecessary testing on healthy volunteers while aiding in drug formulation development.
Introduction: Topical brepocitinib, a tyrosine kinase (TYK)2/Janus kinase (JAK)1 inhibitor, is in development for psoriasis (PsO) and atopic dermatitis (AD). Quantitative analyses of prior clinical trial data were used to inform future clinical trial designs.
Methods: Two phase 2b studies in patients with AD and PsO were used to characterize the amount of topical brepocitinib and the resultant systemic trough concentration (C) using a linear mixed-effects regression (LMER).