Leachables and extractables handbook : safety evaluation, qualification, and best practices applied to inhalation drug products /

• Άλλοι συγγραφείς: Ball, Douglas J.
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : John Wiley & Sons, [2012]
• Θέματα: Drug delivery systems > Standards.; Pharmaceutical services.; SCIENCE > Chemistry > Industrial & Technical.; Electronic books.

A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)'such as metered dose inhalers, dry powder inhalers, and...

Πίνακας περιεχομένων:

• Leachables and extractables handbook; robert kroes: in memoriam; contents; preface; acknowledgments; contributors; part i: development of safety thresholds, safety evaluation, and qualification of extractables and leachables in orally inhaled and nasal drug products; chapter 1: overview of leachables and extractables in orally inhaled and nasal drug products; chapter 2: a general overview of the suitability for intended use requirements for materials used in pharmaceutical systems; chapter 3: concept and application of safety thresholds in drug development.
• Chapter 4: the development of safety thresholds for leachables in orally inhaled and nasal drug productschapter 5: the analytical evaluation threshold (aet) and its relationship to safety thresholds; chapter 6: safety thresholds in the pharmaceutical development process for oindp: an industry perspective; chapter 7: the chemistry and toxicology partnership: extractables and leachables information sharing among the chemists and toxicologists; chapter 8: use of safety thresholds in the pharmaceutical development process for oindp: u.s. regulatory perspectives.
• Chapter 9: the application of the safety thresholds to qualify leachables from plastic container closure systems intended for pharmaceutical products: a regulatory perspectivepart ii: best practices for evaluation and management of extractables and leachables in orally inhaled and nasal drug products; chapter 10: analytical best practices for the evaluation and management of extractables and leachables in orally inhaled and nasal drug products; chapter 11: chemical and physical attributes of plastics and elastomers: impact on the extractables profile of container closure systems.
• Chapter 12: pharmaceutical container closure systems: selection and qualification of materialschapter 13: analytical techniques for identification and quantitation of extractables and leachables; chapter 14: extractables: the controlled extraction study; chapter 15: extractables: case study of a sulfur-cured elastomer; chapter 16: case study of a polypropylene: extractables characterization, quantitation, and control; chapter 17: analytical leachables studies; chapter 18: development, optimization, and validation of methods for routine testing.
• Chapter 19: critical component quality control and specification strategieschapter 20: inorganic leachables; chapter 21: foreign particulate matter: characterization and control in a quality-by-design environment; appendixes; appendix 1: experimental protocol for controlled extraction studies on elastomeric test articles; appendix 2: experimental protocol for controlled extraction studies on plastic test articles; appendix 3: protocol addition, phase 2 studies: quantitative controlled extraction studies on the sulfur-cured elastomer.