'Nonclinical studies' presentation slideshows

Nonclinical studies - PowerPoint PPT Presentation

Quality by Design

Quality by Design

Quality by Design. Questions to Consider. How can we maximize the benefits to the industry and other stakeholders? How can we ensure that this will speed up development and reduce the investment for process and product development?

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1.58k views • 59 slides
Southern Indiana Life Sciences Training Institute

Southern Indiana Life Sciences Training Institute

Southern Indiana Life Sciences Training Institute. Sengyong Lee Ph.D. Associate Professor/Program Chair Ivy Tech Community College Bloomington, IN 47404 BIO 2007. The State of Indiana and the city of Bloomington. Biotechnology in the State of Indiana.

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468 views • 20 slides
Nonclinical Perspective on Initiating Phase 1 Studies for Small Molecular Weight Compounds

Nonclinical Perspective on Initiating Phase 1 Studies for Small Molecular Weight Compounds

Nonclinical Perspective on Initiating Phase 1 Studies for Small Molecular Weight Compounds. John K. Leighton, PH.D., DABT Supervisory Pharmacologist Division of Drug Oncology Products OODP/CDER/FDA. Overview. Nonclinical studies conducted for drug development Historical perspective

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373 views • 17 slides
OUTLINE

OUTLINE

OUTLINE. General recommendations for nonclinical studies to support an NDA Recommendations for nonclinical studies to support an NDA for GL 701 Overview of nonclinical study results for GL 701 DHEA and carcinogenicity. General Recommendations for Nonclinical Studies Prior to Approval.

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351 views • 14 slides
Advisory Committee for Pharmaceutical Science Rockville, MD November 28 and 29, 2001

Advisory Committee for Pharmaceutical Science Rockville, MD November 28 and 29, 2001

Advisory Committee for Pharmaceutical Science Rockville, MD November 28 and 29, 2001. Introduction. Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration. Office of Pharmaceutical Science.

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396 views • 11 slides

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