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Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy
Processes and effects of immunogenicity to biologics - screening methodologies - regulatory mandates - commercial repercussions of unwanted immune responses
Processes and effects of immunogenicity to biologics - screening methodologies - regulatory mandates - commercial repercussions of unwanted immune responses
Differences in GMP Requirements between Drugs and Biologics
Biologics regulations - drug regulations - differences in GMP requirements
Biologics regulations - drug regulations - differences in GMP requirements
Quality Expectations for Drugs and Biologics during Early Development: Phase 2
Phase 2 FDA Guidance Documents - QC studies - CMC quality elements - Common Technical Document CTD - Biologics License Application BLA - New Drug Application NDA
Phase 2 FDA Guidance Documents - QC studies - CMC quality elements - Common Technical Document CTD - Biologics License Application BLA - New Drug Application NDA
