It refers to pharmaceutical equivalents or alternatives whose rate and extent of absorption do not show a significant difference when administered at the same molar dose under similar conditions.
Biopharmaceutics, specifically Bioavailability and Bioequivalence.
It compares the bioavailability of a drug after non-intravenous administration (oral, rectal, transdermal, subcutaneous) with that following intravenous administration.
Intravenous, intramuscular, and subcutaneous routes.
Inactive components of a dosage form that can affect drug solubility, dissolution, and permeability.
Yes, they may not be the same salt or ester.
The dosage form in which the drug is administered.
Because they can lead to increased bioavailability or altered drug effects.
They can alter bioavailability by affecting drug absorption and metabolism.
Dissolution at administration or absorption site.
It is the fraction of the drug absorbed through non-intravenous administration compared with the corresponding intravenous administration of the same drug.
Evaluation of clinical responses.
Absolute bioavailability measures the total amount of drug that reaches systemic circulation compared to an intravenous dose, while relative bioavailability compares the bioavailability of a drug formulation to a reference formulation.
By comparing the area under the curve (AUC) of the active drug in systemic circulation following non-intravenous administration with that of intravenous administration.
Water, buffer, artificial gastric fluid, artificial intestinal fluid, artificial saliva, artificial rectal fluid.
1. Blood level time profile 2. Peak blood level 3. Time to reach peak 4. Area under blood level time curve.
Smaller particles have a larger surface area, leading to faster dissolution and better bioavailability.
The rate and extent at which an active drug ingredient is absorbed and becomes available at the site of action in the body.
Grapefruit juice.
Drug absorption, distribution, metabolism, and excretion.
The amount of a substance that reaches the bloodstream through other means of administration, like oral and sublingual.
The salt or ester of the same therapeutic moiety in identical dosage forms.
They can enhance or inhibit drug absorption.
The dosage form.
To optimize therapy and minimize adverse effects.
The oral route.
Yes, they do not necessarily contain the same inactive ingredients.
Drug products that contain the identical therapeutic moiety or its precursor, but not necessarily in the same amount or dosage form.
By affecting drug solubility, dissolution, and permeability.
pH, temperature, and light exposure.
They are designed and changed to influence the release and absorption of drugs.
To compare the rate and/or extent of absorption of a new drug product or a generic equivalent with that of a recognized standard.
Dissolution rate.
1. Controlled clinical blind or double blind study 2. Observed clinical success or failure.
1. Cumulative amount of drug excreted 2. Maximum excretion rate 3. Peak time of excretion.
Polymorphism refers to drugs existing in different crystalline forms, which can have varying solubility and stabilities.
Degradation of the drug can lead to decreased bioavailability.
1. Plasma concentration-time curve (AUC) measures the total drug exposure over time. 2. Cmax measures the maximum concentration of the drug in plasma after administration.
The rate and/or extent of absorption of a new drug product or a generic equivalent against a recognized standard.
Drug solubility, pH sensitivity, first-pass metabolism, and gastrointestinal transit time.
Another formulation of the same drug, usually an established standard, or administration via a different route.
Whole blood, plasma, serum.
The appropriate polymorph can influence the drug's bioavailability.
Formulation (the contents) and production.
Color of the drug.
Drug products that contain identical amounts of the identical active drug ingredient.
Free drug in systemic circulation.
To achieve desired drug release characteristics.
Bioavailability refers to the proportion of a drug that enters the circulation when introduced into the body and is available for action.
Absolute bioavailability is defined as the fraction of an administered dose of unchanged drug that reaches the systemic circulation, measured by comparing the area under the curve (AUC) of the drug's plasma concentration after non-intravenous administration to that after intravenous administration.
It is defined as 100% of the substance reaching the bloodstream, achievable only through intravenous (IV) means.
Discriminate measurement of blood pressure, blood sugar, blood coagulation time.
They bypass the gastrointestinal system, leading to higher bioavailability and faster onset of action.
No, they do not have to be in the same dosage form.
It significantly impacts drug release and absorption.
Proper formulation and packaging techniques.
Parenteral route.
1. Onset of effect 2. Duration of effect 3. Intensity of effect.
By estimating the bioavailability as area under the curve (AUC) of a certain drug compared with another formulation of the same drug.
Skin permeability and the presence of occlusive dressings.
Measurement of urine excretion.
Tablets, capsules, suspensions, and patches.
These factors can affect the dissolution rate and absorption of the drug, thereby impacting how much of the drug reaches systemic circulation.
