S2C1:Nonclinical Drug Testing

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S2C1:Nonclinical Drug Testing

JanFourman,PhD, EdD,MBA, MSRA

S2C1:Nonclinical Drug Testing

Eli Lilly – Pharma registration for diabetes/endocrine, women/men’s health, neural science, oncology, bone/muscle/joint therapeutic areas – 5 years
Eli Lilly – Pharmacovigilance – 7 years
Eli Lilly – Regulatory Intelligence – 3 Years
Purdue University and Roche Diagnostics – Teaching global pharma development, Africa and US
Consultant for Indiana Technical Assistance Program
Invited conference speaker
Published author

S2C1:Nonclinical Drug Testing
S2C1:Nonclinical Drug Testing

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Nonclinical Drug Testing

Introduction

Trends in Nonclinical Testing

FDA Guidance on Nonclinical Testing Requirements

Types of Nonclinical Studies:

Pharmacology

Toxicity

Chronic Toxicity

Bioavailability (BA)/Bioequivalence (BE)

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