S4C1:Biologics Overview

原文始发于微信公众号(化学音乐文化):S4C1:Biologics Overview

S4C1:Biologics Overview

JanFourman,PhD, EdD,MBA, MSRA

S4C1:Biologics Overview

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

S4C1:Biologics Overview
S4C1:Biologics Overview

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Biologics Overview

Describes the different characteristics of biologics (“large molecule”) and chemically-synthesized (“small molecule”) drugs:

Size

Origin and Structure

Pharmacokinetics/Pharmacodynamics (PK/PD)

Provides overview of what these differences mean to:

Drug Development

Evaluation of Drug Safety

Approach to Clinical Studies

Administration/Drug Delivery

Manufacturing

Customers

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