Genotoxicity testing is an essential tool for drug developers, as it can ensure patient safety in new and established drugs. Genotoxic events can cause irreversible damage and particularly severe health events, which makes it imperative these tests are conducted accurately and efficiently.
Genotoxicity testing is an essential tool for drug developers, as it can ensure patient safety in new and established drugs. Genotoxic events can cause irreversible damage and particularly severe health events, which makes it imperative these tests are conducted accurately and efficiently.
Oligonucleotide drugs (ONs) are synthetic molecules ranging from 12 to 30 nucleotides in length and typically made up of single or double strands of nucleotides. Through Watson-Crick base pairing, these drugs use target messenger RNA (mRNA), which results in the inhibition of gene expression and the prevention of erroneous protein production.
Ensuring the medications we rely on are safe and effective from the moment they leave the manufacturer to when they reach the patient involves rigorous stability testing, a critical process that safeguards drug product integrity under diverse environmental conditions. This testing is crucial in biopharmaceutical development to maintain the safety, efficacy, and quality of drug products (DP) and drug substances (DS). It accounts for potential degradation and the stability of different formulations and packaging configurations, providing data to inform labeling, storage, transport, and handling guidelines.
Learn why testing drug solubility is important across the drug discovery and development continuum.
Repeat dose toxicity studies evaluate the effects of repeat administration over a defined period of time. To get the right toxicity data, what is the right duration for your compound? This blog discusses three possibilities. Toxicity data from repeat dose studies...
To make well-informed decisions about the future of your drug candidate, you need highly accurate and reliable data. Generating such data starts with bioanalytical method development and validation – a precise process that requires support from your testing partner....
In preclinical drug development, biomarkers are used to quantify drug safety and response. In this blog, we trace the use of biomarkers across this spectrum with tips along the way. Biomarker analysis is a critical piece of drug development that helps provide a...
Thorough testing of the absorption, distribution, metabolism, and excretion (ADME) properties of a compound has significant downstream effects on the potential success of a drug. Here’s how early ADME screening in particular helps propel you to a successful IND...
In vitro and in vivo ADME studies provide valuable data about a test article as it moves through preclinical development. In this short guide, we provide an overview of in vivo ADME testing, including why it’s important and how it works. For a successful...
Introducing new drug candidates to preclinical testing is a complex and time-consuming endeavor. It can cost developers more than $1 billion and take a decade to bring a new drug to market. Success rates vary depending on therapeutic area, but a recent study from MIT...
There are times in the laboratory when experienced scientists may question the direction in a protocol. Their experience, having worked on so many studies, may tempt them to consider conducting the testing a little differently than the directions provided to them. If...