First In Animal Summary

PharmOptima expedites many  phases of the drug discovery process by providing expert consultation and laboratory support from the point of target selection to drug candidate selection. An important part of PharmOptima is its First in Animal services, which efficiently evaluate key compounds identified through in vitro screening for in vivo bioavailability, metabolism, pharmacologic efficacy, and tolerance in whole animal models designed to meet your drug target needs. These First in Animal services include:

• Preparing novel drug formulations for local or systemic administration
• Designing and implementing efficient consistent experimental animal models
• Evaluating drug tolerance, including cardiovascular, renal, and CNS endpoints
• Devising sensitive pharmacodynamic (PD) parameters
• Integrating these studies with drug delivery and pharmacokinetics (PK)
• Correlating efficacy with drug exposure to establish PD/PK relationships
• Analyzing data generated within and outside of PharmOptima

By integrating these First in Animal Services with its Biochemical Mechanism of Action, ADME, and Preclinical Development Services, PharmOptima expedites the drug discovery process and substantially increases the chances of clinical success by finding better candidates sooner and identifying potential problems early in the development pipeline.

Animal Facilities and Authorization:

• Rabbit, guinea pig, and small rodent studies conducted in a USDA approved animal facility.
• Studies in larger species coordinated through local contract research organizations.

Standard Animal Models for Drug Tolerance, Efficacy, and Pharmacokinetics:

• Conscious mice, rats, and rabbits with blood, CSF, and/or tissue harvest
• Anesthetized rats for acute cardiovascular and renal monitoring*
• Conscious rats for acute or chronic cardiovascular, renal, and CNS monitoring*

(*primary cardiovascular endpoints include blood pressure, heart rate, and ECG)

Customized Animal Models for Drug Tolerance, Efficacy, and Pharmacokinetics:

• Conscious mice for effects on hair growth
• Anesthetized mice for acute drug exposure and cardiovascular monitoring
• Conscious guinea pigs, hamsters, or gerbils for blood, CSF, or tissue harvest
• Conscious cannulated guinea pigs and rabbits for specimen collection
• Conscious dogs for cardiovascular, renal, fluid balance, and CNS monitoring*
• Other animal models custom designed to expedite your drug discovery program

Scientific Staff:
PharmOptima has 19 scientists and consultants with over 300 years of cumulative pharmaceutical research and development experience in multiple drug discovery categories.

Frequently asked questions about First In Animal testing

1. Now that we've identified some promising leads from our high throughput screen (HTS), what are the next steps in using these compounds to advance our drug discovery efforts?
2. What animal models and experimental endpoints are deemed most important for evaluating my HTS screening leads?
3. How much drug is needed to conduct a meaningful "First in Animal" evaluation of an HTS lead for biological activity and pharmacokinetics?
4. What pharmacokinetic parameters are most important in judging the quality of a screening lead?
5. Can drug tolerance, pharmacologic activity, and pharmacokinetics be examined in single customized protocol to save time, money, and compound supply?