BIOAVAILABILITY

Bioavailability:- 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.

ANDA - Abbreviated New Drug Application.

IND – Investigational New Drug Application.

NDA – New Drug Application.

 

According to the BCS, drug substances are classified as follows:

Class I - High Solubility, High Permeability
Class II - High Permeability, Low Solubility
Class III -High Solubility, Low Permeability 
Class IV - , Low Solubility Low Permeability

• A drug substance is considered HIGHLY SOLUBLE when the highest dose strength is soluble in < 250 ml water over a pH range of 1 to 7.5. 

• A drug substance is considered HIGHLY PERMEABLE when the extent of absorption in humans is determined to be > 90% of an administered dose, based on mass-balance or in comparison to an intravenous reference dose. 

• A drug product is considered to be RAPIDLY DISSOLVING when > 85% of the labeled amount of drug substance dissolves within 30 minutes using USP apparatus I or II in a volume of < 900 ml buffer solutions.