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Last month, FDA commissioner Scott Gottlieb released a statement regarding the implementation of the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. One of the limitations of these acts was in regards to the drug...
Cell-based assays are critical tools in biomedical research, drug discovery, and biotechnology, providing a more physiologically relevant approach to studying cellular functions, behaviors, and interactions. These assays involve using live cells as the biological...
From diagnosing diseases to ensuring food safety and advancing scientific research, ELISA testing provides reliable and accurate results that drive progress and innovation.
Explore the critical aspects of measles testing, including methodologies, importance, and interpretation of results, tailored for laboratory professionals. Measles, a highly contagious viral disease, presents significant public health challenges worldwide. Despite...
On August 19, 2015, the US Center for Disease Control CDC released “NARMS (National Antimicrobial Resistance Monitoring System) Now Human Data." NARMS is an interactive tool which shows how antibiotic resistance for four bacteria has changed during the past 18...
This article delves into the latest advancements in immunotherapy research and development, its various types, and how it's shaping the future of oncology and beyond.
Cell and gene therapy are similar fields of biomedical research aimed at treating genetic diseases and are often combined in treatment.
The Clinical Laboratory Improvement Amendments (CLIA) are federal regulations in the United States designed to ensure the accuracy, reliability, and timeliness of laboratory testing in clinical settings. Implemented in 1988, CLIA establishes standards for all...
The rise of biologic therapies has revolutionized treatment options across various medical fields. However, one critical challenge remains: immunogenicity—the ability of biologic drugs to trigger immune responses in patients. Immunogenicity testing of biologics is...
Toxicology testing is a crucial process that assesses the safety and potential health risks of chemicals, substances, and products. By studying the effects of these substances on living organisms, toxicology testing helps to identify and mitigate risks to human...
Anthrax bacteria testing is crucial to detect, prevent, and manage outbreaks, ensuring public health safety
Using a combination of in vitro, in vivo, and in silico methods, researchers and manufacturers can obtain comprehensive toxicity data that informs product development, risk assessment, and regulatory compliance.
By detecting and quantifying trace amounts of host cell DNA, manufacturers can ensure the safety, quality, and compliance of their products.
Pharmacogenetics is a branch of science that studies how a person's genetics influence their response to pharmaceuticals (read an entry to pharmacogenetics, here). Adverse Drug Reactions (ADRs) are one of the biggest influences in the study of pharmacogenetics, as...
As the medical device industry continues to evolve and innovate, the importance of sterilization validation will remain a key factor in ensuring the safety and success of medical products.
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In the dynamic field of scientific research, diversity and inclusivity are...
Pride Month is a time to celebrate the achievements and contributions of the...
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