Why Medical Writing Services Use Style Guides & Lexicons
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
Tag: Model-informed Drug Development
eChalk Talk: Avoid getting “lost in translation” – Increase confidence in translational research using biosimulation
One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued
PBPK Modeling to Support Bioequivalence & Generic Product Approvals
Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally acting generic drugs.
Drug repurposing: Misconceptions, challenges, and opportunities for academic researchers
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
Certara Announces New Clinical Science Group and Adds Senior Scientific Experts
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
How to Build a Firm Foundation for Your Drug Development Program
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
AAPS PharmSci 360 Annual Meeting
How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline
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.
Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations
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
BioSpace: Africa is the Next Frontier for Biosimulation, as Certara Trains Up Talent
By Gail Dutton Biosimulation is integral to drug development today, with fierce competition for expert scientists to run the simulations and (…)