How Model-informed Drug Development Will Increase R&D Productivity

Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and … Continued

Certara Launches First Global Quantitative Systems Pharmacology Consortium

PRINCETON, NJ – Jan. 25, 2017 – Certara today announced that it is launching a Quantitative Systems Pharmacology (QSP) Immunogenicity Consortium. Modeled after Certara’s highly successful Simcyp Consortium, the QSP Immunogenicity Consortium brings together leading biopharmaceutical companies in a pre-competitive environment to cooperatively develop an Immunogenicity Simulator.

Transforming Drug Product Development the PBPK Way!—A Breakthrough Approach

Developing and optimizing drug formulations― a key component of a product development―is a very lengthy and capital intensive process. Today, most drug candidates are poorly water-soluble; this has led to greater emphasis on screening more complex formulation technologies. Formulation development is still largely an empirical process ― based on trial and error and formulation scientists’ … Continued

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

How MBMA Can Help You Make Smarter Drug Development Decisions

Successful drug development depends on making wise decisions about portfolios, clinical trials, marketing, etc. We’re continuously faced with the challenge of deciding whether to continue development or stop it. To support those decisions, we gather data, typically through clinical trials. We analyze the data from those clinical trials, and then we use these analyses to … Continued

Certara Launches Version 16 of Its Simcyp Population-based Simulator

PRINCETON, NJ – Jan. 10, 2017 – Certara today announced that it has released version 16 of its Simcyp Population-based Simulator. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions (DDIs) and pharmacokinetic (PK) outcomes in clinical populations.

Leveraging Dissolution Testing to Meet Regulatory Guidelines

Dissolution testing is a standard tool in a formulation scientist’s arsenal. When companies make changes to drug products (particle size, excipients, manufacturing process, equipment, etc), health authorities often require comparing dissolution profiles to determine if the reference and test products are equivalent. Generic drug developers are also required to show bioequivalence between the branded drug … Continued