Subchronic and chronic toxicology tests are essential studies that assess long term health effects of test substances, supporting longer clinical study durations and your New Drug Application (NDA) with the FDA. To make informed decisions and hit your timelines, when should these important studies be conducted?
Cancer is a leading global health concern, accounting for approximately 10 million deaths in 2020, according to the World Health Organization’s International Agency for Research on Cancer. Traditional chemotherapy, which uses cytotoxic drugs like DNA base analogs (e.g., 5-fluorouracil), DNA-interacting agents (e.g., actinomycin D), antimetabolites (e.g., methotrexate), and tubulin inhibitors (e.g., paclitaxel), has been the primary treatment for decades. However, these treatments often have a narrow therapeutic window and can cause significant side effects due to non-specific targeting.
In 1919, Jules Bordet received the Nobel Prize in Physiology or Medicine for discovering that heating serum to 56°C does not destroy its antibodies but does render them unable to kill bacteria. Bordet deduced the existence of a heat-sensitive, fragile component in serum that works with antibodies to eliminate bacteria, which he called “complement.” Today, we understand the complement as a multi-molecular system comprising more than 30 soluble proteins, membrane-binding proteins, and receptors, collectively known as the Complement System.
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.
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.
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.
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.
These innovative drugs are poised to revolutionize the pharmaceutical landscape by targeting genes and proteins that small molecules and biologics cannot effectively address.
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.
Despite centuries of medical progress, simultaneously monitoring the human body’s many processes and co-occurring reactions remains difficult. In recent years, researchers have added a crucial tool to understand what’s happening—the ability to measure biomarkers.
The term “biomarker” first appeared in a 1947 paper on fetuin-A detection. Biomarkers are defined characteristics measured as indicators of normal biological processes, pathological processes, or biological responses to exposure or drug intervention, including therapeutic interventions.
Non-clinical testing is a high-stakes process where efficiency and accuracy are paramount. Mistakes can cost time and money and, more importantly, derail drug development.