9781909030343_FrontCover -- Contents -- Paper 1 Introduction to extractables and leachables -- Paper 2 European regulatory perspective on extractables and leachables -- Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives -- Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy -- Paper 5 The problematic and concrete cases concerning large volume parenteral drugs -- Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachables -- Paper 7 A risk based approach to qualify process aids with respect to E&L's -- Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products -- Paper 9 Toxicological evaluation of E&Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice -- Paper 10 Extractables and leachables in topical products during development -- Paper 11 Extractables & Leachables in the life cycle of dialysis solutions -- Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulations -- Paper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables -- Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications -- Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers -- Paper 16 The leachables simulation process -- strategies for study design and development and case studies -- 9781909030343_BackCover.