Deep learning/artificial intelligence concepts have been around for decades, with significant advancements made in the late ‘80s and throughout the ‘90s as scientists experimented with recurring neural networks (RNNs). As our concept and expectations of deep learning evolved over the years, data quality and the computing power needed to train and deploy new models often … Continued
Drug development continues to be painfully slow and mind-bogglingly expensive. In a 2010 article, Stephen Paul estimated that developing a new drug cost $1.8 billion and took thirteen years on average from discovery to regulatory approval. These excesses occurred because drug development is a fundamentally complex and risky process that is also subject to rigorous … Continued
Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for the initiation of clinical drug trials, and these applications have commonalities and differences throughout the world. If you’re initiating clinical trials in multiple countries, then planning for these different submissions is critical to the efficiency of your drug program. Many … Continued
This blog explains how Certara’s Simcyp team developed and tested a model in the Simcyp PBPK Simulator for rectal drug absorption.
As the pharmaceutical industry continues to evolve, so too do the processes for regulatory submissions. One significant development is the introduction of eCTD (Electronic Common Technical Document) 4.0 (read this blog to get a primer on eCTD if you’re not familiar with it). This latest iteration promises to overhaul the way pharmaceutical companies submit their … Continued
The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for exchanging nonclinical data related to drug development. SEND was developed by the Clinical Data Interchange Standards Consortium (CDISC), a globally recognized, not-for-profit organization that develops data standards with the input of pharmaceutical industry experts. The FDA requires drug developers to use … Continued
With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical stage, the market for bsAbs is projected to grow to >$30B by 2028. The distinct advantages of bsAbs, such as improved selectivity and specificity, increased efficacy, and lower toxicity, will result in measurable benefits for cancer patients. But bsAbs are … Continued
Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV show, and for some inexplicable reason, hammer pants were a viable fashion option. But while 90’s era political, entertainment, and fashion trends may have come and gone, many regulatory guidances from that time are still in effect. In my role … Continued
Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because of its ability to reduce and potentially eliminate the need to conduct clinical trials in this special population. However, much of the early research into pediatric PBPK models has concentrated on the North European and American populations. Growing interest in … Continued
Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued
