PK/PD Support for Drug Approvals
Certara Strategic Consulting provides high-quality, regulatory-compliant PK/PD analyses that are the basis of your regulatory submission package. On more than 100 client engagements per year, our pharmacometricians apply our world-class expertise and technology to support nonclinical and clinical study analysis for new drug approvals.
We use the latest versions of Phoenix® WinNonlin®, Phoenix NLME™, IVIVC Toolkit™ for Phoenix WinNonlin, and the Phoenix Knowledgebase Server™ Online (PKS™ Online) to ensure that your analyses are carried out to the highest professional standards, in minimum time, at competitive rates.
PK/PD Analysis Using Industry-Standard Phoenix WinNonlin
- Noncompartmental analysis (NCA) – sparse or rich data analysis
- Compartmental analysis – semi-physiological PK/PD modeling
Early Clinical Studies
- Phase I – MTD, SAD, MAD, BA/BE, Food Effect, DDI studies; studies in special populations (e.g., renal and hepatic impaired patients), QT prolongation studies
- Phase II – Studies in patients for dosing requirements (Phase IIa) and efficacy (Phase IIb)
In Vivo-In Vitro Correlation (IVIVC) Using IVIVC Tookit for Phoenix WinNonlin
- Modified-release formulation and Super Generics [505(b)(2) submissions]
- Fixed-Dose Combination (>2 products combined into 1 tablet formulation)
- Drug delivery systems (e.g., transdermal, parenteral, pulmonary)
Our methods are simple, efficient, and robust. You receive the highest quality analysis, leading to protocols optimized for:
- Number of samples – a key cost driver
- Sampling schedule – to improve your picture of PK
We can support your strategic drug development decisions and new drug approvals through quantitative analysis and predictive models of diseases, drugs and clinical trials.