S4C2:Biologic Clinical Considerations

原文始发于微信公众号(化学音乐文化):S4C2:Biologic Clinical Considerations

S4C2:Biologic Clinical Considerations

JanFourman,PhD, EdD,MBA, MSRA

S4C2:Biologic Clinical Considerations

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

S4C2:Biologic Clinical Considerations
S4C2:Biologic Clinical Considerations


Biologics OverviewPart 1 – Introduction

Safety with Biologics Introduction:

Gain a better understanding of biologic agents, risk factors and potential Mechanism of Actions (MOAs) as it relates to safety

Part 2 – Preclinical Considerations

Nonclinical safety evaluation general concepts

Biologics approach

Supporting First Human Dose (FHD)

Species selection

Tissue cross-reactivity

Repeat-dose toxicity

Regulatory filing considerations

Immunogenicity and immunotoxicity assessments

Developmental and reproductive toxicity testing

Carcinogenicity assessment


打赏 为好文打赏 支持药时代 共创新未来! 为好文打赏 支持药时代 共创新未来!
上一篇 2020年2月18日 12:29
下一篇 2020年2月18日 23:54