Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
Preclinical Safety
The Crucial Role of Biomarkers in the Precision Medicine Revolution
Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
Acute Toxicity Studies: 3 Best Practices to Stay on Track with Your IND Timeline
Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
3 Common Missteps in Nonclinical Safety Assessment Testing
Safety assessment testing is one of the most involved and complex pieces of an already time-intensive and costly drug development process. Any missteps here can have drastic implications on the rest of your development program. Here are three common pitfalls to avoid....
What Is IND-Enabling Testing & What Does It Include?
IND-enabling testing is a cornerstone of the drug development process, helping researchers predict safety concerns and estimate safe and efficacious starting doses for clinical trials. Planning ahead, understanding the tests you need to conduct, and diligent tracking...
Understanding Oligonucleotides and Their Bioanalytical Considerations
As new modalities in drug development gain popularity, we are in an exciting place to treat and prevent complex disease states. Researchers have been making great strides in the development of oligonucleotides, otherwise known as “oligos.” Though these therapies...
Basic Questions Developers Are Asking About In Vitro-In Vivo Extrapolation
In Vitro-In Vivo Extrapolation (IVIVE) is an emerging discipline that helps researchers predict the rate at which compounds metabolize within the human liver and are eliminated from the body (i.e., human clearance rate). Put simply, IVIVE uses in vitro methods to...
Good Communication Essential To Successful Preclinical Testing
For both large and small drug development companies, good communication displayed throughout the preclinical testing process is essential to success. Project leaders who exhibit great awareness, flexibility and communication skills can’t be undervalued in the timely...
Understanding Differences in Regulatory Requirements Vital to Efficient Design of Preclinical Programs
There are many factors involved in designing a preclinical drug safety assessment program, but among the priorities is having a good understanding of the different requirements from the various regulatory agencies in which the Investigative New Drug (IND) will be...
PROTACs and Their Role in Catalyzing Health Solutions
PROTACs, otherwise known as PROteolysis TArgeting Chimera, emerged as a novel therapeutic modality in drug development and currently show promising clinical results for tackling some of the most complex diseases. PROTACs are designed to leverage the body’s internal...
An Important First Step in the Design of a Preclinical Program
In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...
PART 2 – Understanding New Modalities: Prodrugs, Cell/Gene Therapy and Fusion Proteins
New drug modalities, including oligonucleotides, bispecific antibodies, prodrugs, cell and gene therapies, and fusion proteins, offer new ways to treat human diseases once considered "untreatable." Cell and gene therapies have been around for years, but advancing...