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RAS Capabilities —
Preclinical PK Analysis

RAS 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

Bioanalytical and DMPK Consultation

TK/PK Analysis and Reporting

RAS 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 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.
  • Physiologically-based PK Modeling: predict drug exposure in tissues and organs, mechanistic extrapolation [high-dose to low-dose, route-to-route, animal-to-human].

Allometric Scaling

RAS 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.

Bioanalytical and DMPK Consultation

RAS 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.