Rocky Mountain Regional Center of Excellence

Pre-Clinical Development

What is pre-clinical development?
The development of a program defining in vitro and in vivo analysis of activity, efficacy, and pharmacology; the creation of bioanalytical methods used to measure safety, toxicokinetics, and pharmacokinetics of a product.

Why is it needed?
This program will be used to assure safety and efficacy of a product prior to the initiation of an IND submission and clinical investigation.

PDM Core Services

Service 1:
Product safety (21 CFR 610.11) 

Service 2:
Product sterility (21 CFR 610.12)

Service 3:
Product integrity (21 CFR 610)

Service 4:
Product potency (21 CFR 610.21) 

Service 5:
Product purity (21 CFR 610.13) 

Service 6:
Product stability (21 CFR 211.166) 

Service 7:
Toxicology 

Service 8:
Pharmacology 

Service 9:
Adventitious agent

What do I need to do?
Please contact the PDM Core for specifics on the program and individualized service agreements.

E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu