Bioavailability and Bioequivalence Studies

Vocabulary flashcards covering the key concepts, pharmacokinetic parameters, and regulatory guidelines of bioavailability and bioequivalence studies based on the lecture transcript.

Bioavailability (BA)

The proportion of an administered drug that reaches systemic circulation in an unchanged form, expressed as a percentage of the total dose.

Absolute Bioavailability (F)

A type of study that compares the oral formulation of a drug with an intravenous (IV) reference dose.

Relative Bioavailability

A measurement that compares two different oral formulations of the same drug.

Single-dose crossover design

The most common study design used to compare how different drug formulations behave in the body by analyzing their pharmacokinetic (PK) profiles in the same group of subjects.

Washout period

The time interval between two treatment phases in a study that ensures the first drug is completely eliminated from the body to prevent carryover effect.

$C_{max}$ (Maximum Concentration)

The peak plasma concentration reached after drug administration.

$T_{max}$ (Time to $C_{max}$)

The time taken to reach the peak concentration ($C_{max}$).

AUC (Area Under the Curve)

A pharmacokinetic parameter representing the total drug exposure over time.

$T_{1/2}$ (Half-life)

The time taken for the drug concentration in the body to reduce by half.

Bioequivalence Studies

Studies conducted for generic drug approval to compare generic versus branded drug formulations.

$80\%-125\%$ Range

The FDA guidelines specifying the range within which the AUC and $C_{max}$ of a generic drug must fall to establish bioequivalence.

Physiological Factors

Factors affecting bioavailability including metabolism, age, gastric pH, and enzyme activity.

Formulation-related Factors

Variables such as solubility, excipients, and drug release mechanisms that affect bioavailability.

Route of Administration

The path by which a drug is taken into the body, including oral, IV, sublingual, and transdermal methods.