Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation 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.

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Reference-Scaled Average Bioequivalence

Ana Henry

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 (i.e. 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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Topics: Model-based Drug Development, PK/PD Modeling and Simulation

Postcards from the Road: Phoenix Fall Tour

Ana Henry

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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Topics: Model-based Drug Development, PK/PD Modeling and Simulation

How to Use Phoenix RSABE templates

Traditional average bioequivalence (ABE) methodology requires prohibitively large sample sizes when used with highly variable drugs and drug products (HVDs/HVDPs), which are defined as products with intra-subject CV% of the reference greater than 30%. This increases the expense of BE studies, places more study subjects at risk, and ultimately limits the availability of generics. Reference-scaled […]

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Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

Ana Henry

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 bioequivalant to the reference drug. Bioequivalence (BE) studies can also be required for pharmaceutical variations made […]

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Topics: PK/PD Modeling and Simulation

Meet FDA Bioequivalence Criteria with WinNonlin RSABE Templates

Ana Henry

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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Topics: Drug Safety, Model-based Drug Development, PK/PD Modeling and Simulation, Training

Why Phoenix NLME is the best in class solution for Pop PK/PD

Ana Henry

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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Topics: PK/PD Modeling and Simulation
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