PDF⋙ Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations: 6 (AAPS Advances in the Pharmaceutical Sciences Series)
Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations: 6 (AAPS Advances in the Pharmaceutical Sciences Series) Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations: 6 (AAPS Advances in the Pharmaceutical Sciences Series) PDF, ePub eBook D0wnl0ad This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, a