New Drug Development - Biopharmaceutical Review
Pharmacokineticists evaluate the rate and extent to which the drug's active ingredient is made available to the body and the way it is distributed in, metabolized by, and eliminated from the human body.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
Biopharmaceuticals vs. drugs - Cleaning assessment and monitoring - Strategies for efficient cleaning validation - Risk assessment - ICH guidelines
Biopharmaceuticals vs. drugs - Cleaning assessment and monitoring - Strategies for efficient cleaning validation - Risk assessment - ICH guidelines
Managing Immunogenicity Risk in Biopharmaceuticals
Risk factors associated with immunogenicity - Regulatory expectations on immunogenicity testing - Minimizing risk - Phase specific sampling plan
Risk factors associated with immunogenicity - Regulatory expectations on immunogenicity testing - Minimizing risk - Phase specific sampling plan
