The Certara Blog

Author: Ana Henry

Ana Henry is a director of product management for Phoenix products at Certara. In her free time, she enjoys playing soccer and spending time with her family biking, traveling, and camping.

Recent Posts

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 […]

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Postcards from the Road: Phoenix Fall Tour

We’ve just returned from the third leg of our now annual Phoenix roadshow. In this leg, I helped deliver workshops in Beijing, Osaka and Tokyo. In total, our product development team has visited eight cities in the US, Europe and Asia.  We gave both technical and scientific PK/PD modeling presentations to more than 250 clients. […]

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Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

Did you know that 84% of the 4 billion prescriptions written each year are for generic drugs? Clearly, generics are a big business. Regulatory agencies, such as the FDA, require generic drug manufacturers to show that generic drugs are bioequivalent to the reference drug. Bioequivalence (BE) studies can also be required for pharmaceutical variations made […]

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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 […]

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Why Phoenix NLME is the Best in Class Solution for Pop PK/PD

Over the past 20 years, I have seen a number of significant changes in the pharmaceutical industry’s approach to the study of pharmacokinetics and pharmacodynamics (PK/PD). With the high risk and large expense associated with drug development, it is imperative to have the best PK/PD analytical tools to aid in understanding the safety/efficacy profile of […]

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