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Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.

Pharsight Consulting Services

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From Discovery through Development

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Introduction to Certara Consulting Services - helping 17 new drugs get approved in the last two years

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PK/PD Analysis

PK/PD Support for New Drug Approval 

Pharsight's Consulting Services team provides high-quality, regulatory-complaint PK/PD analyses that are the basis of your regulatory submission package. On more than 100 client engagements per year, we apply our world-class expertise and technology to support nonclinical and clinical study analysis for new drug approval. 

We use the latest versions of Phoenix® WinNonlin® and Pharsight Knowledgebase Server™ (PKS™) 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®

  • 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)

Benefits

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
  • Dose
  • Populations

We work in close collaboration with Pharsight’s Medical Writing team to deliver regulatory-compliant study reports based on our analyses.