Year: 2016
Certara Thought Leaders to Chair Strategic Pharmacology Discussions at AAPS Annual Meeting
PRINCETON, NJ – Nov. 9, 2016 – Certara announced that it will be chairing three sessions and participating in six more at the 2016 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting & Exposition.
IVIVC Software – Achieving Regulatory, Formulation and Manufacturing Success
In vitro-in vivo correlation (IVIVC) is an important, predictive mathematical tool in drug development, used to enhance product and process understanding with the ultimate goal of ensuring consistent performance throughout the product’s life cycle.
Phoenix WinNonlin Validation Suite
The Phoenix WinNonlin Validation Suite is a desktop application that provides objective evidence of Phoenix WinNonlin functionality and streamlines the validation process through the use of automated tests accessed through a graphical user interface and validation document templates.
The Ultimate Cheat Sheet on CDISC-SEND
On December 18, 2016, numerous regulatory agencies will require electronic submission of non-clinical data using CDISC’s standard format. What exactly are CDISC data standards and how will they impact drug developers? In this blog post, I will provide an overview of the CDISC SEND data standard, review some of the requirements for implementing SEND, and … Continued
CDISC Data Standards: Understanding the Guidance for Standardized Study Data
In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. The study data requirement is not retroactive and will only apply to … Continued
The Impact of Genetic Polymorphisms and DDIs on Exposure
Physiologically-based pharmacokinetic (PBPK) modeling and simulation is increasingly accepted due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study — particularly relating to assessing complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the … Continued
Certara to Participate in 19 Sessions at ACoP7
PRINCETON, NJ – Oct. 21, 2016 – Certara today announced it will be participating in 19 sessions at the Seventh American Conference on Pharmacometrics (ACoP7). This year’s conference is being held from Oct. 23-26 in Bellevue, Washington.
Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug
Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone … Continued