July 2016

Blog

Assessing Drug-Smoking Interactions Using PBPK Modeling

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn't…

CertaraJuly 29, 2016

Blog

How to Prepare a Study Data Standardization Plan (SDSP) for FDA

Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…

CertaraJuly 25, 2016

Publication

Towards a Best Practice Approach in PBPK Modeling: Case Example of Developing a Unified Efavirenz Model Accounting for Induction of CYPs 3A4 and 2B6

CertaraJuly 20, 2016

White Paper

Model-based Meta-analysis: An Innovative Methodology Comes of Age

MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…

CertaraJuly 14, 2016

Brochure

D360™ Scientific Informatics Platform for Drug Discovery and Development

Discovery drug research requires understanding complex biological, chemical, logistical and computational data from a wide…

CertaraJuly 14, 2016

Publication

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime…

CertaraJuly 12, 2016

Publication

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

The Simcyp® Simulator provides a framework for mechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic modelling of potentially interacting drugs.…

CertaraJuly 9, 2016

Blog

Status of QSP Modeling in the Pharmaceutical Industry

A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…

CertaraJuly 6, 2016

Publication

Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development

CertaraJuly 1, 2016

Publication

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…

CertaraJuly 1, 2016

July 2016

Assessing Drug-Smoking Interactions Using PBPK Modeling

How to Prepare a Study Data Standardization Plan (SDSP) for FDA

Towards a Best Practice Approach in PBPK Modeling: Case Example of Developing a Unified Efavirenz Model Accounting for Induction of CYPs 3A4 and 2B6

Model-based Meta-analysis: An Innovative Methodology Comes of Age

D360™ Scientific Informatics Platform for Drug Discovery and Development

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

A Tutorial on Pharmacodynamic Scripting Facility in Simcyp

Status of QSP Modeling in the Pharmaceutical Industry

Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development

More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances

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