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Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:
Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.
Chapter 1: Introduction to Analytical Method Validation | Download PDF |
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Chapter 2: Analytical Instrument Qualification | Download PDF |
Chapter 3: HPLC Method Development and Optimization with Validation in Mind | Download PDF |
Chapter 4: Method Validation Basics | Download PDF |
Chapter 5: Robustness and System Suitability | Download PDF |
Chapter 6: Setting Specifications and Investigating Out-of-Specification Results | Download PDF |
Chapter 7: Validation by Type of Method | Download PDF |
Chapter 8: Analytical Method Transfer | Download PDF |
Chapter 9: Implementing New Technology in a Regulated Environment | Download PDF |
prelims | Download PDF |
Glossary | Download PDF |
Appendix | Download PDF |
Index | Download PDF |