M8 Bioavailability and Bioequivalence in Drug Development

Bioavailability

Fraction of drug reaching systemic circulation.

Bioequivalence

Absence of significant difference in drug performance.

Drug Product Performance

Release of drug leading to bioavailability.

Pharmacodynamic Response

Body's response to a drug's pharmacological effects.

Adverse Events

Unintended harmful effects from drug administration.

Bioequivalence Studies

Compare bioavailability of same drug products.

Formulation

Specific combination of ingredients in a drug.

In Vivo

Studies conducted within a living organism.

Clinical Trial

Research study to test drug efficacy and safety.

FDA Regulations

Guidelines for drug approval and bioequivalence.

tmax

Time to reach peak plasma concentration.

Cmax

Maximum drug concentration after administration.

AUC

Area under plasma concentration-time curve.

MEC

Minimum effective concentration for therapeutic effect.

MTC

Minimum toxic concentration causing adverse effects.

Onset Time

Time until drug effect begins after administration.

Duration of Action

Time drug remains effective above MEC.

Phase IV Clinical Trial

Post-marketing study for drug performance.

Pharmacokinetic Study

Study of drug absorption and distribution.

Disintegration Test

Measures how quickly a drug breaks down.

Dissolution Test

Measures drug release in solution.

Biogesic Example

Different formulations of the same drug product.

Narrow Therapeutic Index

Small margin between MEC and MTC.

Formulation A vs B

Comparison of different drug formulations' performance.

Stability Studies

Tests to ensure drug maintains efficacy over time.

In Vitro Comparison

Testing drug performance outside a living organism.

Formulation A

Rapid response formulation with Cmax of 6 mcg/mL.

Formulation B

Delayed response formulation with Cmax of 3.5 mcg/mL.

Relative Bioavailability (Frel)

Bioavailability of formulation A as a percentage.

Absolute Bioavailability

Bioavailability compared to intravenous administration.

Pharmaceutical Substitution

Dispensing a pharmaceutical alternative for prescribed drug.

Therapeutic Substitution

Dispensing a therapeutic alternative in place of prescribed drug.

Pharmaceutical Alternatives

Different salts or esters of the same therapeutic moiety.

Pharmaceutical Equivalents

Same dosage form with identical active ingredients.

Therapeutic Equivalents

Pharmaceutical equivalents expected to have same clinical effect.

Excipients

Inactive ingredients that aid drug formulation.

Tmax

Time to reach maximum concentration in blood.

Drug Absorption

Process of drug entering systemic circulation.

Therapeutic Objectives

Goals for drug efficacy and safety.

Modified-Release Formulations

Formulations designed to release drug over time.

Fixed-Dose Combinations

Formulations containing multiple active ingredients.

Drug-Drug Interactions

Effects when two or more drugs are taken together.

Food Effects

Impact of food on drug absorption and efficacy.

Therapeutic Alternatives

Different active ingredients for similar therapeutic effects.

Systemic Circulation

Blood circulation that delivers drugs throughout the body.

Drug Development

Process of bringing a new drug to market.

Therapeutic Effect

Desired outcome of drug treatment.

Pharmacodynamic Activity

Drug's effects on the body and its mechanisms.