Pharmacokinetic (PK) assays are a crucial stage of drug development. They help ensure the safety and effectiveness of new therapeutics by establishing how drugs are absorbed, distributed, metabolized, and excreted in the body.
Regulatory
Bioanalytical Strategies for Peptide-Drug Conjugates (PDCs): Optimized Approaches for the Pharmaceutical Industry
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.
Validating Flow Cytometry-Based Micronucleus Assays in Alternative Species
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.
How to Evaluate the Preclinical Safety of Oligonucleotide Drugs
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.
Tackling Development and Regulatory Challenges for Gene Therapies
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...
Dose Range-Finding Studies for Safety Assessment: 3 Reasons Not to Skip Them
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...
4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing
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...
A New Method to Improve Identification of the Payload-Containing Catabolites of ADCs
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...
Improving PROTAC Drugs with MetID Studies
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...
What Are Metabolite Profiling & Identification Studies?
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...
GLP vs. Non-GLP toxicology studies: When to use which guidelines?
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 Interaction: An Overview of Substrates and Metabolizing Enzymes
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...