Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally acting generic drugs.
Tag: Model-informed Drug Development
Drug repurposing is promoted as a cost- and time-effective mechanism for providing new medicines. Often, however, there is insufficient consideration by academic researchers of the processes required to ensure that a repurposed drug can be used for a new indication. This may explain the inability of drug repurposing to fulfill its promise.ll
Multi-Disciplinary Expansion and New Appointments Grow Capacity and Capabilities PRINCETON, N.J.— September 22, 2021. Certara, a global leader in biosimulation, today announced that it is expanding its Integrated Drug Development (IDD) division with a new clinical science group, headed up by Philippa Marshall, M.D., Vice President of Clinical Science. The Company also appointed David Mitchell, … Continued
Developing an investigational drug and attaining regulatory approval is much like the process of building a house. First, both require coordinating many stakeholders. Building a home requires hiring various tradespeople like carpenters, plumbers, electricians, and more. And you’ll have to oversee and coordinate all their work, which must be done in a certain order. You … Continued
Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials assessing oncology drugs.
The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated virus serotype 2 (AAV2) vector expressing the gene for human retinal pigment epithelium 65 kDa … Continued
By Gail Dutton Biosimulation is integral to drug development today, with fierce competition for expert scientists to run the simulations and (…)
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK) of an investigational oligonucleotide drug is an important part of its pre-clinical development program as well as informing its later clinical development. In this blog, … Continued
The PMDA enters 8th consecutive year of using Certara’s biosimulation software PRINCETON, N.J.—June 23, 2021. Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ and Phoenix™ biosimulation software. The PMDA has been using Certara’s biosimulation software since 2014. The Simcyp … Continued