Cover -- Half Title -- Series Page -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Preface -- Author -- Chapter 1 Background and Introduction -- 1.1 The Impact of Pharmaceutical Companies -- 1.1.1 Modern Industrial Hygiene in the Pharmaceutical Industry -- 1.1.2 Risk Management Overview -- 1.2 Industrial Hygiene and Risk Management within the Pharmaceutical Industry -- 1.3 Summary -- Notes -- Chapter 2 Risk Assessment: Hazard Identification and Dose-Response Evaluation -- 2.1 Introduction -- 2.2 Hazard Identification -- 2.2.1 Epidemiological Studies
2.2.2 Animal Bioassays (In Vivo Studies) -- 2.2.3 In Vitro Assays -- 2.2.4 Structure Comparison -- 2.2.5 Finding the Relevant Hazard Identification Data -- 2.2.6 Hazard Identification Summary -- 2.3 Dose-Response Assessment -- 2.3.1 Dose-Response Curves -- 2.3.2 Use of In Vitro Studies -- 2.3.3 Evaluating the Quality of the Study -- 2.3.4 Creating Occupational Exposure Limits (OELs) -- 2.3.4.1 Evaluating the PoD Criteria -- 2.3.4.2 Evaluating the BW Criteria -- 2.3.4.3 Evaluating the UFc and PK Criteria -- 2.3.4.4 Evaluating the V Criteria -- 2.3.4.5 Calculating the OEL
2.3.5 Exposure Banding and OELs -- 2.3.6 Drawbacks of Exposure Banding -- 2.3.7 Integration Into the ISO 31000 Risk Management System -- 2.4 Summary -- Notes -- Chapter 3 Industrial Hygiene Risk Assessment: Exposure Assessment -- 3.1 Introduction -- 3.2 Identifying What Needs to Be Sampled -- 3.2.1 APIs and Active Ingredients -- 3.2.2 Excipients -- 3.2.3 Flavors and Colors -- 3.2.4 Biologicals -- 3.2.5 Antibody-Drug Conjugates (ADCs) -- 3.2.6 Other Substances of Concern -- 3.3 Identifying How Sampling Will Be Performed: Method Selection and Analytical Sensitivity -- 3.3.1 Surrogates
3.3.2 Non-Specific Methods -- 3.3.3 Sampling for Parts of a Whole -- 3.3.4 Enzyme-Linked Immunosorbent Assays (ELISA) -- 3.4 Identifying Where to Sample -- 3.5 Identifying Who and When to Sample -- 3.6 Identifying How Many Samples to Acquire and Presumptive Costs -- 3.7 Evaluating Controls of an Operation -- 3.8 Summary -- Notes -- Chapter 4 Industrial Hygiene Risk Assessment: Risk Characterization -- 4.1 Introduction -- 4.2 Establishing Criteria for SEG Risk Characterization -- 4.2.1 The 95th Percentile -- 4.2.2 AIHA Exposure Categories -- 4.3 Industrial Hygiene Risk Characterization
4.3.1 Qualitative Characterization: Risk Matrices -- 4.3.2 Difficulties with Applying Risk Matrices to Industrial Hygiene Risk Characterization and Other Significant Drawbacks -- 4.3.3 Quantitative Characterization: Identifying the 95[sup(th)] Percentile -- 4.3.3.1 Traditional Statistics -- 4.3.3.2 Bayesian Statistics -- 4.4 Summary -- Notes -- Chapter 5 Risk Treatment: Control Banding -- 5.1 Introduction -- 5.2 Before Selecting an Engineering Control -- 5.2.1 Pharmaceutical Control Banding -- 5.2.1.1 Performance-Based Exposure Control Limits -- 5.2.1.2 Modern Pharmaceutical Control Banding
