Title: Method Validation in Pharmaceutical Analysis
Abstract: Preface.List of Contributors.Part I: Fundamentals of Validation in Pharmaceutical Analysis.1 Analytical Validation within the Pharmaceutical Environment (Joachim Ermer).2 Performance Parameters, Calculations and Tests.3 Case Study: Validation of an HPLC-Method for Identity, Assay, and Related Impurities (Gerd Kleinschmidt).Part II: Life-cycle Approach to Analytical Validation.4 Qualification of Analytical Equipment (David Rudd).5 Validation During Drug Product Development - Considerations as a Function of the Stage of Drug Development (Martin Bloch).6 Acceptance Criteria and Analytical Variability (Hermann Watzig).7 Transfer of Analytical Procedures (Mark Broughton and Joachim Ermer (Section 7.3)).8 Validation of Pharmacopoeial Methods (John H. McB. Miller).9 Analytical Procedures in a Quality Control Environment (Raymond A. Cox).10 Aberrant or Atypical Results (Christopher Burgess).11 Future Trends in Analytical Method Validation (David Rudd).Index.
Publication Year: 2014
Publication Date: 2014-08-15
Language: en
Type: book
Indexed In: ['crossref']
Access and Citation
Cited By Count: 189
AI Researcher Chatbot
Get quick answers to your questions about the article from our AI researcher chatbot