'Qbd approach' presentation slideshows

What Impact should ICH Q8 have on ICH Q6A Decision Trees?

What Impact should ICH Q8 have on ICH Q6A Decision Trees?. Ajaz S. Hussain, Ph.D. Deputy Director, OPS/CDER/FDA. Outline. An overview of ICH Q6A dissolution decision trees Relationship between disintegration and dissolution test? Mechanistic basis? Causal link?

1k views • 27 slides

Interim Risk Assessment Report

National Institute for Pharmaceutical Technology and Education (NIPTE). Interim Risk Assessment Report. Initiate Quality Risk Management Process. Risk Assessment. Risk Identification. Risk Identification. Risk Analysis. Risk Analysis. Risk Evaluation. Risk Evaluation. unacceptable.

547 views • 15 slides

ONDQA Perspective on Post Approval Changes

ONDQA Perspective on Post Approval Changes. Eric P. Duffy, PhD Director, Division of Post-Market Evaluation, ONDQA, CDER, FDA Public Meeting: Supplements and Other Changes to an Approved Application Feb. 7, 2007,Gaithersburg MD. Overview. What is quality by design (QbD)?

412 views • 12 slides

GPhA Proposed Pathway for Quality by Design Dissolution Testing and Setting of Specifications for Generic Drugs

251 views • 10 slides