Ficheiro de 0,97 MB em formato PDF (82 p.).

1 Introduction. 2 What Is Science. 2.1 The Scientific Method. 2.1.1 Observation. 2.1.2 Hypothesis. 2.1.3 Prediction. 2.1.4 Experimentation. 2.1.5 Conclusion. 2.1.6 Data. 2.1.7 Interpretation. 2.2 Science vs. Art. 3 Forensic Chemistry. 3.1 Current State. 3.2 How to Improve. 4 Code of Federal Regulations (21CFR) Guidances. 4.1 Good Manufacturing Practices (GMP). 4.1.1 Method Development. 4.1.2 Reference Standards. 4.1.3 Analytical Method Transfer. 4.1.4 Training. 4.2 Good Laboratory Practices (GLP). 4.2.1 Personnel. 4.2.2 Handling Test and Control Article. 4.2.3 Maintenance and Calibration of Equipment. 4.2.4 Reporting of Results. 4.2.5 Standard Operating Procedure. 4.2.6 Reagents and Solution labeling. 4.2.7 Conduct of Laboratory Study. 4.2.8 Retention of Records. 5 International Committee on Harmonization (ICH). 5.1 Validation of Analytical Procedures. 5.1.1 Specificity. 5.1.2 Linearity. 5.1.3 Accuracy. 5.1.4 Precision. 5.1.5 Quantitation Limit. 5.1.6 Detection Limit. 5.1.7 Robustness. 5.2 Quality Risk Management. 5.3 Quality Assurance System. 6 International Organization for Standards (ISO). 6.1 Management Requirements (Clause 4). 6.2 Technical Requirements (Clause 5). 7 Statistical Considerations. 7.1 Normal Distribution. 7.2 Significance . 7.3 Confidence Intervals. 7.4 Outlier Data. 7.5 Linear Regression. 7.6 Required Sample Replicates. 7.7 Method Performance. 7.8 Uncertainty Measurement. 7.9 Sampling Strategies. 8 Conclusion. Index.