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.
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.
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
Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally acting generic drugs.
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.— 2021 年 9 月 22 日. 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
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