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From the Blog

Reference-Scaled Average Bioequivalence

Author: 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 […]

Tips for custom IVIVC models in Phoenix

Author: Simon Davis Original Poster Link The IVIVC tool within Phoenix is a convenient and powerful tool to build an in vivo-invitro correlation model using dissolution experiments and real in vivo profiles.  This module can support your organisation in formulation development and even in applying for Biowaivers. The tool has a flexible library of built-in models […]

How Biosimulation is Changing Drug Development

PK/PD modeling and simulation is a part of a larger science called biosimulation, and it is changing drug development. We are using complex models to simulate clinical responses that help us develop medicines more rapidly and with greater safety. Check out this short video on how Certara is leading this biosimulation effort.   Disclaimer: This […]

Advanced PK/PD Data Analysis Training – Dan Weiner

Intermediate PK/PD Modeling Methodology Training – Dan Weiner