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...
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...
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...
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...
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, 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...
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...
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...
Pathologists examine the causes and mechanisms of diseases and, in the world of drug development, that means collecting, processing and analyzing tissue for toxicity. Histotechnologists fix tissue samples onto slides, stain them to distinguish types of cells and cell...
The newest partnership between Quanterix and WuXi AppTec Laboratory Testing Division (LTD) integrates industry-leading instruments and reagents with world-class laboratory and technical staff to form the co-developed Simoa Joint Lab in Shanghai. Starting in 2021, drug...
Encountering challenges while developing a new drug is expected, but drug developers who understand the pitfalls are often better prepared to navigate them and emerge successfully. Nonclinical safety assessment is a highly complex and molecule-specific process, but...
We offer a true, single-platform, end-to-end solution that can be catered to your specific drug discovery and development needs – saving you money while providing industry-leading turnaround times. With solutions for both small- and large-molecule development, our...