Bioavailability
Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.
For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)
Strategic Planning for an ANDA - Communication with the FDA - ANDA content and format - FDA-sponsor meetings planning and handling - CMC data expectation - bioequivalence/ bioavailability
Strategic Planning for an ANDA - Communication with the FDA - ANDA content and format - FDA-sponsor meetings planning and handling - CMC data expectation - bioequivalence/ bioavailability
Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities
Drug Master File (DMF) Submission - FDA requirements - NDA - ANDA - IND - Export Application - Processing and Review - Transfer of Ownership - DMF closure
Drug Master File (DMF) Submission - FDA requirements - NDA - ANDA - IND - Export Application - Processing and Review - Transfer of Ownership - DMF closure
Practical Strategies to a successful 505(b)(2) product
505(B)(2) regulation and guidance from the FDA - strategic considerations - challenges - solutions - future trends
505(B)(2) regulation and guidance from the FDA - strategic considerations - challenges - solutions - future trends
