Chan, a consultant in analytical method development and validation, preformulation, formulation development, and chemistry, manufacturing, and controls strategy building, et al. survey the delivery systems for the administration of therapeutic agents--conventional therapeutic delivery, medical device therapeutic delivery, and cellular therapeutic delivery--and their regulatory requirements. They address the regulatory issues in pharmaceutical, cell therapy, and medical device submission; traditional pharmaceutical drug therapy development; current trends and strategies of combination medical devices therapy development, including bone graft delivery systems and the delivery of insulin; innovations in cellular and stem cell therapeutic delivery, such as cancer cell therapeutic delivery, endocrine therapeutic delivery, and cell-based biologic therapy; and the analytic support needed for research and development, including specifications setting and stability studies requirements, LC-MS (liquid chromatography-mass spectrometry) techniques, biorelevant methods, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines for development and global harmonization, and OOS (out of specification)/atypical result investigation. Contributors are an international group of pharmaceutical, biologics, and other specialists. Annotation ©2015 Ringgold, Inc., Portland, OR (protoview.com)
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