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Why are GLP Toxicology Studies Important?

Why are GLP Toxicology Studies Important?

Good Laboratory Practice (GLP) regulations have played a critical role in raising the standards of drug development around the world for decades, establishing rules and criteria to ensure the quality and integrity of nonclinical safety data submitted to regulatory bodies.

Designing Juvenile Toxicology Studies: Key Considerations for Drug Development

Designing Juvenile Toxicology Studies: Key Considerations for Drug Development

Developing pediatric treatments is a complex and nuanced process that requires meticulous planning and execution. One critical aspect of this process is juvenile toxicology studies, which ensure the safety and efficacy of drugs intended for pediatric use. As drug manufacturers approach new treatments and therapies, the following are considerations for designing and conducting juvenile toxicology studies, emphasizing comprehensive assessment and reliable results.

How Radionuclide Drug Conjugates are Transforming Cancer Treatment

How Radionuclide Drug Conjugates are Transforming Cancer Treatment

With cancer treatments drastically transforming in the last decade, radionuclide drug conjugates (RDCs) offer effective, precise treatment and diagnosis while minimizing side effects. RDCs worldwide have already received regulatory approval, and more will soon follow as researchers aim to continue improving efficacy, safety, and personalization. In this article, we dive into RDCs’ benefits and challenges.

5 Ways You Can Automate Preclinical Bioanalysis

5 Ways You Can Automate Preclinical Bioanalysis

In drug development, efficiency, accuracy, and consistency pave the way for faster market entry. Automating each stage of the drug development process, particularly preclinical bioanalysis, accelerates research and ensures quality test results.

The Advantages of LC-MS/MS in Optimizing ADC Bioassays

The Advantages of LC-MS/MS in Optimizing ADC Bioassays

Antibody-drug conjugates (ADCs) are offering hope to cancer patients worldwide. This novel treatment combines the precision targeting of antibodies with the cancer cell-killing power of cytotoxins, delivering treatments directly to tumors and minimizing damage to healthy tissues.

IND Studies: Understanding Early-Stage Regulatory Needs

IND Studies: Understanding Early-Stage Regulatory Needs

Bringing new drugs and therapeutics to a global market requires extensive planning. Requirements for soliciting early-stage regulatory feedback differ across geographies, so it might be tempting to file new drug submissions separately.