02352nam a2200277 4500 393654 9783319097251 393654 20151215d2014 y0pory50 ba eng Good laboratory practices for forensic chemistry Recurso eletrónico Thomas Catalano Heidelberg Springer 2014 1 CD-ROM 12 cm SpringerBriefs In Pharmaceutical Science & Drug Development 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. QUÍMICA FORENSE 343048 CIÊNCIA FORENSE 321508 LABORATÓRIO DE POLÍCIA 343233 NORMA DE QUALIDADE 349142 REGULAMENTO 234525 GUIA DE INFORMAÇÃO 1233 CATALANO Thomas 357943 Oferta 0 PJCD_270_000000000000000 2022-06-06 PJCD270 426117 PJ PJ PJ1CD270_63 PJCD270 2022-06-06 0 MO Oferta