Validation of Bioanalytical Methods (essentials) 9783658389123, 9783658389130, 3658389125
this book, the validation of bioanalytical methods is described. In the quality control of biological medicinal products
121 63 725KB
English Pages 59 [54]
Table of contents :
What You Can Find in this Essential
Contents
1: Introduction
2: Method Categories
3: Validation Parameters
3.1 Accuracy
3.2 Precision
3.3 Further Validation Parameters
4: Validation Environment and Validation Planning
4.1 Validation Environment: The Big Difference Between Academic and GMP Laboratories
4.2 Validation Planning
5: Validation of Bioanalytical Methods
5.1 Identity: Validation of a PCR Test
5.2 Determination of Content: Validation of a Virus Titration
5.3 Qualitative Impurities: Validation of a Test for Absence of Microorganisms (Sterility)
5.4 Quantitative Impurity: Validation of an Endotoxin Assay
6: Errors, Problems and Risks Associated with Insufficient Method Validation
7: Summary
What the Reader Can Take Away from this Essential
References
What You Can Find in this Essential
Contents
1: Introduction
2: Method Categories
3: Validation Parameters
3.1 Accuracy
3.2 Precision
3.3 Further Validation Parameters
4: Validation Environment and Validation Planning
4.1 Validation Environment: The Big Difference Between Academic and GMP Laboratories
4.2 Validation Planning
5: Validation of Bioanalytical Methods
5.1 Identity: Validation of a PCR Test
5.2 Determination of Content: Validation of a Virus Titration
5.3 Qualitative Impurities: Validation of a Test for Absence of Microorganisms (Sterility)
5.4 Quantitative Impurity: Validation of an Endotoxin Assay
6: Errors, Problems and Risks Associated with Insufficient Method Validation
7: Summary
What the Reader Can Take Away from this Essential
References
- Author / Uploaded
- Patric U. B. Vogel
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