Publication

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

A collaboration between the Consortium for Innovation and Quality in Pharmaceutical Development and the Cardiac…

CertaraJanuary 1, 2014

Knowledge Base

Cassette Dosing: Advantages and Challenges

Cassette dosing is a technique primarily used in drug discovery efforts in non-clinical studies to…

CertaraDecember 16, 2013

Publication

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Treprostinil diolamine (oral treprostinil) is a prostacyclin analogue under evaluation for the treatment for pulmonary…

CertaraDecember 1, 2013

Publication

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

In environments where complete mechanistic knowledge of the system dynamics is not available, a synergy…

CertaraDecember 1, 2013

Publication

Absence of Pharmacokinetic Drug-drug Interaction of Pertuzumab with Trastuzumab and Docetaxel

Pertuzumab is a novel antihuman epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody. Combined…

CertaraNovember 24, 2013

On-Demand Webinar

Phoenix WinNonlin: A State of the Art Software Tool for Pre-clinical PK and TK Analysis

Are you currently using Excel for PK/TK analysis? Phoenix WinNonlin streamlines analyses and generates all…

CertaraNovember 21, 2013

Knowledge Base

What is Identifiability?

Developing models for pharmacokinetic or pharmacodynamic data requires creativity, patience, and hard work. Sometimes that…

CertaraNovember 18, 2013

On-Demand Webinar

Introduction to Population PK/PD Analysis Using Phoenix NLME

Phoenix NLME provides sophisticated algorithms and powerful and flexible data processing and modeling tools for…

CertaraNovember 14, 2013

Publication

Predicted Heart Rate Effect of Inhaled LABA PF-00610355 in Volunteers and COPD Patients

The aim of this study was to assess the cardiovascular effects of a new inhaled…

CertaraNovember 1, 2013

Knowledge Base

What is the -2LL or the Log-likelihood Ratio?

Understand the 2LL (Log-likelihood Ratio) and its role in statistical analysis. Explore how it aids…

CertaraOctober 28, 2013

Modeling and Simulation – PK/PD

The IQ-CSRC Prospective Clinical Phase 1 Study: Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?

Cassette Dosing: Advantages and Challenges

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment

Modeling of Pharmacokinetic Systems Using Stochastic Deconvolution

Absence of Pharmacokinetic Drug-drug Interaction of Pertuzumab with Trastuzumab and Docetaxel

Phoenix WinNonlin: A State of the Art Software Tool for Pre-clinical PK and TK Analysis

What is Identifiability?

Introduction to Population PK/PD Analysis Using Phoenix NLME

Predicted Heart Rate Effect of Inhaled LABA PF-00610355 in Volunteers and COPD Patients

What is the -2LL or the Log-likelihood Ratio?

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