Nikhilesh Paliwal

About Nikhilesh Paliwal

Experience on Physiologically based pharmacokinetic modelling and simulation (WinNonlin…

Experience

1. Manager Safety Pharmacology

   Abbott

   Sep 2021 — Present · Mumbai, IN

   Provide scientific support to further development of established pharmaceuticals in the area of pharmacology and pharmacokinetic studies.Provide scientific insight to the new product innovation in terms of disease pathology, pharmacology and safety. Participate in scientific peer review of preclinical team output.Provide preclinical proof of concept (POC) efficacy study conceptualization for product innovation & development. Propose, initiate, monitor and report pharmacodynamic (PD)/Pharmacokinetics (PK) studies of new/established pharmaceuticals to support regulatory submission.Demonstrated expertise in prediction of human pharmacokinetics (human dose) and safety exposure margin employing various techniques like allometry and in vitro in vivo extrapolations (IVIVE). Perform pharmacokinetic/pharmacodynamic (PK/PD) and PBPK modelling and simulation to support the projects at lead optimization and candidate selection stage. Expertise in PK/PD model Fixed effect, Linear, Log Linear, Emax/Sigmoid Emax model along with model fitting using Direct and Indirect models (Turnover, link model and irreversible effect model) used for modelling and simulations to aid in dose selection for long term efficacy and safety studies.Actively involved in Pop-PK (FOCE_LB and Laplacian method) using Phoenix NLME and toxicokinetic data analysis using WinNolin Enterprise Software (Version 8.1).Provide expert statements to regulatory authorities on preclinical efficacy of New Chemical Entities (NCE’s) and established products. Prepare/update nonclinical part of regulatory documents (e.g. dossiers, IB) for established products.

Education

• Vinayaka Mission's Research Foundation - University

  Doctor of Philosophy - PhD

  2017 — 2022

• Nagpur University

  Master of Pharmacy

  2010 — 2012