Analytical Method Development and Validation
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€65.99
advanced HPLC validation techniques
Analytical Method Development
Analytical Performance Parameter
AOAC
Approaching Method Development
Category=PNF
chromatographic analysis
collaborative
Dissolution Testing
Documented Validation Process
drug
Drug Substance
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FDA guidelines
HPCE
Ich
Ich Guideline
Ich Process
ICH standards
installation
interlaboratory
Interlaboratory Collaborative Studies
LCL.
Low LOQs
method transfer protocol
Method Validation
Optimal Emission Wavelengths
PDA
Perimental Design
pharmaceutical quality control
Practices cGMP Current Good Manufacturing
qualification
regulatory compliance
Residual Standard Deviation
RSD
Sample Preparation
studies
substance
suitability
system
System Suitability Tests
tests
USP
USP Chapter
Product details
- ISBN 9780824701154
- Weight: 180g
- Dimensions: 138 x 216mm
- Publication Date: 16 May 1997
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Paperback
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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Michael E. Swartz, Ira S. Krull
