Bozeman, MT (PRWEB) May 22, 2013
BioScience Laboratories clinical laboratory has again exceeded market standards for Phase 1 Dermatological Safety Studies for an IND submission. Twenty-two years of experience has refined our processes and set our practice apart. Phase 1 Dermatological Safety Studies represent a critical transition into the human model for every IND and ANDA submission. Sponsors require quality safety data in a reasonable amount of time, with a reasonable fee. Shorter turn-around times increase project progress and allow efficacy trials to initiate sooner.
From start to finish, Phase 1 Repeat Insult Patch Test, Cumulative Irritation Patch Test, Phototoxicity and Photoallergy Evaluations were conducted within a twelve week timeframe. This includes Protocol Development, IRB review, subject recruitment, study management, CRF drafting and printing, document archiving, data management, statistical analysis and ICH final reports.
All subjects recruited were healthy volunteers; BioScience Laboratories, Inc. utilized an expansive 15,000 subject database to fill and complete the Phase 1 Dermatological Safety studies, consisting of:
- 200 subject RIPT, A Randomized, Controlled Study to Evaluate the Sensitizing Potential of the Investigational Product Using the Repeat Insult Patch Test Design
- 30 subject Cumulative Irritation, 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of the Investigational Product Using the Cumulative Irritant Patch Test Design
- 30 subject Phototoxicity, 4-Day, Randomized, Controlled Study to Evaluate the Photoirritation Potential of the Investigational Product, Using the Phototoxicity Patch Test Design
- 50 subject Photoallergy, Randomized, Controlled Study to Evaluate the Photoallergic Potential of the Investigational Product, Using the Photoallergic Patch Test Design
The Pharmaceutical and Biotechnology industry demand outsourcing that delivers value and Bioscience Laboratories Inc. has delivered that value consistently for over 20 years.
About BioScience Laboratories, Inc
For over twenty years, our testing laboratories has conducted investigative studies for both standard and customized in-vitro and clinical studies proving product safety and efficacy on a wide range of products spanning the public consumer industry, healthcare industry, food-handling industry, and the cosmetics market. ASTM, AATCC, AOAC,CLSI, and EN standard methods are performed on a regular basis at our testing labs to support EPA, FDA, TGA and HC registrations and label claims. Our GLP/GCP-compliant Microbiology, Virology, and Clinical Laboratories are audited by various regulatory bodies, individual auditors, and continue to meet the highest quality & standards in the industry. We are very astute in statistical design and evaluate all of our studies with statistical analysis.
We are constantly scanning the competitive environment to assist our customers in gaining a strategic competitive advantage in their respective industries. We are recognized as a leading authority for topical antimicrobial testing: an estimated 90% of all hospital-related topical antimicrobials have been tested at BSLI.
For more information, price quotes, any other questions or concerns please contact:
John Dyba, MCRA - Senior Account Executive
(406) 587-5735 EXT: 119