PML School: Custom PK/PD Modeling Made Easy

In our increasingly noise-filled world, sometimes, the most powerful insights come from listening. As the head of support at Certara, I get excited about listening to our clients’ pharmacokinetic/pharmacodynamic (PK/PD) modeling dilemmas and helping them solve them. And through listening to our users who call our support hotline, attend our training courses, or participate in … Continued

What’s New in Phoenix 7.0!

On September 14, Dr. Nathan Teuscher presented an informative webinar focused on new features and enhancements in Phoenix® 7.0, which was released on August 10. This blog post summarizes the topics discussed during the presentation. Nathan began his presentation with an overview of new features in Phoenix 7.0 including: A new graphics engine for high … Continued

On the Road Again: Leveraging the Power of Phoenix

Last year during our inaugural Phoenix Roadshow workshop program across the US, Europe and Asia, we gained valuable feedback and ideas from our customers on “All Things Phoenix.” Based on the success of that program, and with new updates and case studies to share with our users, we commenced our 2nd Annual Phoenix Roadshow in … Continued

Get Ready for CDISC-SEND!

Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and … Continued

Reference-scaled Average Bioequivalence

The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an  approved (ie, reference) drug in their rate and extent of absorption. The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under … Continued

Meet FDA Bioequivalence Criteria with WinNonlin RSABE Templates

A study by the FDA Office of Generic Drugs (OGD) reviewed over 1000 bioequivalence (BE) studies of 180 drugs, of which over 30% were highly variable (HV). Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of … Continued

Positive Stats About PK/PD Modeling in the Pharmaceutical Industry

Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation (M&S) is an important tool that can help researchers gain a better understanding of their drug’s efficacy— especially at the early stages of drug development. In this blog post, I’ll discuss some positive statistics uncovered in a recent IQ Consortium survey that examined the current landscape for preclinical PK/PD modeling … Continued

Common Misconceptions About Computer System Validation

Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug. To satisfy regulatory expectations, these computer systems should be validated. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data … Continued

Commonly Held Myths About the FDA’s CDISC Mandate

Have you heard the FDA will require electronic submissions that use CDISC standardized study data? In my work at Certara, I’ve noticed there’s a lot of confusion, and even significant apprehension, surrounding this issue. To combat the misconceptions about what these regulations will mean for drug developers, I’ve compiled a list of common questions (and … Continued