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ICH Guideline Q8 Pharmaceutical Development
the main target is to build the quality into the product, prior the actual testing procedure.
This presentation consist a consolidated list all Regulatory Guidelines for Cleaning Validation. Hy...
Good Clinical Practices for drug discovery and development
1) Introduction 2) ICH Q8 guidline 3)Regulatory and Industry views on QbD 4)Scientifically Based Qb...
GCP is a set of guidelines for how clinical trials should be carried out. It ensures that the data...
Genotoxic impurities and analysis
In these slides you can get the information of clinical trials which have four phase I,II,III, IV. b...
unit 1 product formulation and development
Current Good Manufacturing Practices (cGMP) form the scientific foundation of pharmaceutical quality...
Slides prepared for IIUM GCP Workshop
NARGUND COLLEGE OF PHARMACY
Regulatory perspective of clinical trials, phases of clinical trials,ICH-GCP Principles
COMMON TECHNICAL DOCUMENT , its granularities, benefits, advantages, shortcomings.
ICH
Thrombolysis with rt-PA (Actilyse) is approved for the treatment of acute ischemic stroke since 1996...
The Pharmaceutical Quality by Design is a systematic approach to development that begins with prede...
Bioethics in research
This is the short notes on ICH guidlines Q and S.
GCP guidelines for clinical research
Validation: Action of proving and documenting that any process, procedure or method actually and con...
Good clinical practice ICH GCP E6
Pharmacy
International Guidelines and Regulatory Agencies for Toxicity Studies