Nikunjkumar Patel

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This study aimed to demonstrate the added value of integrating prior in vitro data and knowledge-rich physiologically based pharmacokinetic (PBPK) models with pharmacodynamics (PDs) models. Four distinct applications that were developed and tested are presented here. PBPK models were developed for metoprolol using different CYP2D6 genotypes based on in(More)
There are two main reasons for drug withdrawals at the various levels of the development path – hepatic and cardiac toxicity. The latter one is mainly connected with the proarrhythmic potency and according to the present practice is supposed to be recognized at the pre-clinical (in vitro and animal in vivo) or clinical level (human in vivo studies). There(More)
Spontaneous superior mesenteric artery (SMA) dissection is a rare, but potentially fatal disease. Prompt diagnosis and treatment of SMA dissections result in a lower prevalence of intestinal infarction and mortality. In the current era, imaging techniques can promptly diagnose SMA dissection; however, no definitive guidelines have been established to treat(More)
The attention and interest in establishing in vivo/in vitro correlations (IVIVCs) is grounded in its tremendous utility as a prognostic tool. It can be used to support formulation optimization, predict in vivo drug exposure across a potential patient population, select a biologically relevant in vitro dissolution test condition, and support the use of in(More)
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