02186nam a2200229   4500001000700000010001800007100004100025101000800066200009200074210003100166215002000197225006400217300004800281330146500329606002201794606002201816606003101838606002301869606001601892606002701908700002101935393654  a9783319097251  a20151215d2014       y0pory50      ba  aeng  aGood laboratory practices for forensic chemistrybRecurso eletrónicofThomas Catalano  aHeidelbergcSpringerd2014  a1 CD-ROMd12 cm  aSpringerBriefs In Pharmaceutical Science & Drug Development  aFicheiro de 0,97 MB em formato PDF (82 p.).  a1 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.  aQUÍMICA FORENSE  aCIÊNCIA FORENSE  aLABORATÓRIO DE POLÍCIA  aNORMA DE QUALIDADE  aREGULAMENTO  aGUIA DE INFORMAÇÃO  aCATALANObThomas