®Preclinical PK Analysis
Pharsight offers the following unique combination of PK analysis services, delivered by expert staff using leading methods and Pharsight software, to support your preclinical drug development needs:
TK/PK Analysis and Reporting
Allometric Scaling
PBPK Modeling
Bioanalytical and DMPK Consultation
TK/PK Analysis and Reporting
Pharsight provides toxicokinetic and pharmacokinetic analysis to support understanding of the developability and safety of drug candidates in humans:
- Noncompartmental PK/PD Analysis: sparse or rich TK/PK analysis in animals leveraging Phoenix WinNonlin and AutoPilot; delivery of preclinical PK report.
- Compartmental Analysis and Simulations: semi-physiological PK/PD modeling and simulation of very sparse and rich animal data.
Allometric Scaling
Pharsight provides three allometric scaling approaches, with particular advantages for biologics and for boosting the confidence of scaling adult parameters and predictions to pediatric population:
- FDA Approach: conversion factors based on body surface area, see FDA Guidance.
- Scaling of NCA Parameters: scaling of clearance according to body weight, resulting predictions for 70kg subject.
- Scaling of Compartmental Parameters: all PK parameters, plus mechanistic approach that allows simulation of subject concentration-time profiles after single and multiple dose.
PBPK Modeling
Pharsight provides expert services in physiologically-based pharmacokinetic (PBPK) modeling to predict drug exposure in tissues and organs, and to support mechanistic extrapolation of high-dose to low-dose, route-to-route, and animal-to-human.
- PBPK For Chemical Risk Assessment: model development and application for chemical risk assessment and analysis of environmental compounds, leveraging Trial Simulator.
Bioanalytical and DMPK Consultation
Pharsight provides expert guidance on the role of ADME and bioanalysis in pre-clinical drug development, including study design and selection.
- Bioanalysis: bioassay selection of small and large molecules, quantitative and qualitative LC-MS/MS approaches, cross-validation studies.
- Drug Metabolism/Pharmacokinetics (DMPK): in vivo and in vitro metabolite identification/profiling, preclinical strategies and planning, recommendations for preferred partnerships.
- Investigational New Drug (IND) Applications: comprehensive documentation including: tox results, TK/PK results in all species, allometry, dosing recommendations for FIH study and Phase I protocol.