Comprehensive Clinical and In-Vitro Testing Services
Tailored to Your Needs
At Bioscience of Bozeman, we offer GCP-compliant clinical trials and GLP In-Vitro services tailored to your needs. Our study implementation and scheduling process is customer focused to keep you up to date throughout the study process. Direct access to our study team allows better communication resulting in a more specific and focused study. We look forward to working with you, again.
Cumulative Irritation Evaluations
Bioscience provides comprehensive clinical evaluations for cumulative skin irritation, adhering to FDA/CDER guidelines outlined in the Skin Irritation and Sensitization Testing Guidance for Industry (December 1999). These evaluations ensure your products meet regulatory standards for safety and effectiveness.
Study Requirement
Our cumulative irritation studies are designed to test the skin’s response to repeated exposure over 21 days. Key elements include:
- Testing the drug product, its vehicle (product without active ingredients), a high-irritancy control (sodium lauryl sulfate), and a low-irritancy control (0.9% saline).
- For products requiring bioequivalency data (ANDA), we also test an Innovator patch for comparison.
- Daily application of small quantities to occlusively patched sites on the upper back of 30+ subjects.
Irritation levels are scored daily, assessing:
- Erythema (redness).
- Vesiculation (blistering).
- Peripheral extension (spreading irritation).
Our rigorous protocols ensure accurate and reliable results, supporting your product’s compliance with FDA requirements and market readiness. Bioscience’s expertise in irritation testing provides confidence in your product’s safety profile.
Participate in our research
Volunteers needed!
Volunteers drive medical breakthroughs by helping researchers test new treatments and therapies. Join us as a volunteer and be a key part of advancing public health—your participation could lead to tomorrow’s life-saving discoveries.
