Exam 1: Drug Delivery: An Evolving Concept

Drug absorption is often limited by the presence of which of the following barriers?

Bioavailability is an important pharmacodynamics parameter.

Fill in the blank: The new molecules need to be tested for toxicities in both________ and________ dosing because toxicological concerns are key factors in determining the developability of a drug and are a major cause of attrition.

Toxicological studies for a new molecule are only required for acute dosing.

Fill in the blank: No drug can be commercially viable if it does not meet the criteria for optimum ____________,good safety profile (sufficient therapeutic window),and minimal_______________.

An in vivo model should have all the biochemical,cellular,and physiological complexities of human systems to successfully predict the actual efficacy of the drug candidate.

Match the Factors affecting drug development The lead molecule being developed should have optimum absorption,distribution,metabolism,and excretion in humans.

Bioavailability,volume of distribution and elimination half-life are important__________ parameters.

As long as the active drug is safe toxicological studies for its metabolites are not required.

The setting of druggability and developability criteria depends on factors such as commercialization and scientific feasibility.

The crystalline state,salt form,and the presence of formulation excipients do not have any bearing on the overall stability of a drug.

Fill in the blanks in the figure below.

In the initial stages of drug discovery,new bioactive molecules are generally identified by

Total body clearance is the rate at which the systemic circulation eliminates the active drug.

__________ dosing is the most common and convenient way to administer most drugs.

A drug needs to be commercially viable even if it does not meet the criteria for optimum therapeutic efficacy,good safety profile (sufficient therapeutic window),and minimal adverse effects.

Match the Factors affecting drug development The new molecules need to be safe in both acute and chronic dosing.

For most drugs (unless they are rapidly acting) low to moderate clearance is preferred.

Fill in the blank: Often,the drug is required only at the physiological___________,and hence extensive biodistribution may cause ___________and unwanted side effects.

Match the Factors affecting drug development The lead molecule being developed should have optimum stability,solubility and minimum interaction with excipients.