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Preclinical Pharmacology: 

Preclinical Pharmacology Pacific BioLabs Hercules, CA

Preclinical Pharmacology: 

Preclinical Pharmacology Early work may be performed in cell cultures, when appropriate Performance of candidate drugs in an animal system provides early evidence of its potential

Preclinical Pharmacology: 

Preclinical Pharmacology Preclinical evaluations use cell culture and animal responses as predictors of human responses with the goals of assuring safety and effectiveness in humans


Pharmacology/Toxicology Preclinical pharm/tox data are used to: Identify target organs/tissues Identify need for specialized safety monitoring Identify toxicological profile Select starting doses/regimens

Developing a Strategy: 

Developing a Strategy Case by case assessment based on clinical application Start with standard methods Postulated mechanism of action will drive more specialized investigations into a drug’s activity

Developing a Strategy: 

Developing a Strategy Pharmacokinetics/pharmacodynamics Bioavailability Dose ranging/dose confirmation Potency determination Immunogenicity Custom animal models


Pharmacokinetics Absorption Distribution Metabolism Excretion Need to track the drug in specimens Bioanalytical determination (“cold”) Radiolabel counts (“hot”) Species: mouse or rat, then dog and/or primate


Bioavailability Compare blood levels of drug delivered by intravenous route to intended route of administration Commonly oral or topical Species: mouse, rat, or rabbit, then dog and/or primate

Topical Drug Delivery: 

Topical Drug Delivery Significant focus on transdermal drug delivery Iontophoretic delivery Passive patch Creams Formulations to promote absorption or deposition Delivery devices require dual assessment as drug and device Specialized studies look at layers of skin Species: rabbit and pig

Dose Ranging/Confirmation: 

Dose Ranging/Confirmation Multiple dose levels to discover optimum therapeutic level Minimum adverse effects (risk vs. benefit) Dose confirmation to verify earlier findings Maintain same species for comparability Species: mouse, rat, dog, primate

Potency Determinations: 

Potency Determinations Some drugs have a readily measured therapeutic effect Insulin, therapeutic toxins Response can be quantified Potency of preparation can be calculated based on dose response compared to standard


Immunogenicity Development of an immune response to the test article may be desirable or undesirable Studies look at antibody response after multiple doses of the test article over time Species: rabbit

Animal Models: 

Animal Models Simulations of human condition May be normal state in animal that is very similar to human May be a diseased condition that is created in order to be treated

Normal Animal Models: 

Normal Animal Models Cardiovascular system: pigs, dogs, primates Skin: pigs, primates Eye: rabbits

Animal Models of Disease: 

Animal Models of Disease Photo aging in hairless mice Psoriasis in SCID mice Tumors in rats Obesity in mice Transgenic/”knockout” mice Some work, some don’t


Summary Every program is different, tailored to the activity of the test article Use same species throughout pharm/tox program Get regulatory buy in on plan

Pacific BioLabs : 

Pacific BioLabs THANK YOU!

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