Clinical Research

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Overview

 

Testing of candidate drugs in humans is conducted to evaluate safety and the efficacy in treating, preventing, or diagnosing a specific disease or condition. The most important consideration in these studies is the safety of trial participants. Human testing occurs in FDA-supervised, phased clinical trials, along with further assays to characterize absorption, distribution, metabolism, and excretion (ADME) and toxicity associated with the lead candidate(s) that made it through earlier phases of testing. Show more

Clinical trials can take many forms and increasingly enroll a range of different populations. However, patient populations may be stratified in clinical trials when data suggest that a particular group may respond better to a specific treatment regimen. Generally, there are three or four phases during drug development. Phase 0 is increasingly included for investigational new drugs (INDs). This phase involves testing of subtherapeutic doses on a small number of subjects to confirm that the animal studies are valid in humans.

If a drug candidate passes Phase 0, the clinical trial will progress to Phase I, designed to evaluate drug safety, side effects, and dosage range in a small cohort. Phase II usually extends the trial to a larger cohort and compares the putative drug to a placebo. Typically, Phase III broadens the scope of Phase II to more study subjects, often with different populations, and includes comparisons to one or more existing treatments as well as further monitoring and evaluation of adverse events. Phase IV involves population studies after the market release of a new drug.Show less

 

Featured Article
Monitoring Antibody Immune Responses against Biotherapeutic Drugs

 


Solutions for Clinical Research

Critical Raw Materials for Clinical Diagnostics

Critical Raw Materials for Clinical Diagnostics

Browse a selection of critical raw materials for developing human diagnostics such as inflammation markers, tumor antibodies, and antigens for common tumor types.

Antigens
Diagnostic Antibodies
Acute Phase Proteins

Protein Analysis and Quantitation

Protein Analysis and Quantitation

Use our comprehensive protein analysis tools for fast, reproducible quantitation of proteins, including antibodies, with built-in controls and validation steps to meet regulatory needs.

GS-900™ Calibrated Densitometer and Regulatory Tools (CFR validated for cGMP)
Western Blotting Reagents and Equipment
Multiplex Immunoassays

Antibodies

Antibodies

Choose from our extensive range of antibodies designed for in vitro diagnostic clinical assays or utilize our custom antibody services including custom manufacturing.

Antibodies by Application
Antibodies by Target Species
HuCAL® Custom Antibody Services

Autoimmune Kits and Instruments

Autoimmune Kits and Instruments for In Vitro Diagnostics

Explore a range of enzyme immunoassay kits and automated instrumentation specifically designed and approved for autoimmune testing and diagnosis in clinical trials.

Systemic Autoimmune Testing
Gastrointestinal Autoimmune Testing
Instrumentation

Additional Methodolgies and Research Within Drug Discovery and Development

Biomarker Discovery

Biomarker Discovery
The use of biomarkers across drug discovery and development and into the clinic is key to enabling close monitoring of a drug candidate’s effects. Biomarkers can range from specific molecules such as a protein, a gene sequence, or expressed RNA to physiological parameters such as blood pressure. Biomarkers may be detected in a specific location or tissue or in plasma and other bodily fluids.

Biochemical and Cellular Assays

Biochemical and Cellular Assays
Biochemical and cellular pharmacology teams develop and validate assays to support research across drug discovery and development. These assays range from discovery approaches with high sample throughput to high-content analysis to gain an understanding of biological response both in vitro and in vivo.

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