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...
Drug-drug interaction (DDI) signifies an essential facet of pharmacological science, given its influence on drug efficacy and the potential for adverse events. DDI occurs when the pharmacological or clinical response to a drug is altered by the presence of another...
Unexpected side effects can occur when two or more drugs are co-administered. These are called Drug-Drug Interactions (DDIs). Most drugs rely on enzymes to be metabolized. These interactions can alter the efficacy of a drug and potentially be harmful or less...
Gene therapies have been one of the fastest-growing fields of drug development. These therapies hold the potential to treat cancers and other “undruggable” diseases and could hold the key to saving millions of lives. But they also have unique characteristics that make...
Are you ready for your GLP toxicology studies? Not without dose range-finding studies, you aren’t. Here are 3 reasons why these can’t be skipped. A well-planned preclinical toxicology program always starts with the end in mind. In the case of dose levels, then, you...
DMPK testing helps drug developers investigate how a drug compound is absorbed, distributed, metabolized, and eliminated (ADME) by the body. The earlier these properties can be understood, the better – which is why many drug developers start the process with non-GLP...
Antibody-drug conjugates (ADCs) are a relatively new medicine with the potential to target cancer cells and deliver a toxic payload, all while minimizing any damage to otherwise healthy body parts. ADCs have a number of strengths, but perhaps chief among them is...
Most drugs undergo some level of transformation once they enter the body. This metabolism process allows a drug's active pharmaceutical ingredient (API) to achieve its desired effect and eliminate it from the body. But metabolism can also be tricky. Metabolizing a...
High-resolution quadrupole time-of-flight (QTOF) gas chromatography–mass spectrometry (GC-QTOF-MS) provides a powerful combination of high mass accuracy with trace level detection capabilities. Applying the technique to extractables and leachables testing (E&L)...
Drug metabolism studies (the “DM” of DMPK) are a critical part of understanding drug efficacy and safety across the entire drug development continuum. In this blog, we provide an overview of metabolite profiling and identification studies, including: four types of...
Since 1978, when the U.S. FDA issued the Guidance for Industry Good Laboratory Practices Regulations, Good Laboratory Practices (GLP) have been an essential part of the quest to ensure the highest standards in drug development. GLP regulations have ensured that...
Drug-Drug Interactions (DDIs) occur when a drug affects the efficacy of another drug that is being co-administered, which can result in unexpected side effects. Most drugs are metabolized in the body by enzymes, and changes to these enzymes can alter the effects of...