Bio equivalence studies from biopharmaceutics and pharmacokinetics pptx.

Bioequivalence studies are conducted to compare the rate and extent of absorption of a generic drug with that of an innovator (reference) drug, ensuring both products deliver the same therapeutic effect at the same dosage. These studies are usually carried out in healthy human volunteers under controlled conditions, measuring pharmacokinetic parameters like Cmax (maximum concentration), Tmax (time to reach Cmax), and AUC (area under the curve). If the test drug falls within the accepted statistical range (typically 80–125% for Cmax and AUC) compared to the reference drug, it is considered bioequivalent. This ensures that generic medicines are as safe and effective as branded ones, without the need for extensive clinical trials.

1. BIO EQUIVALENCE STUDIES by Anusha BIOPHARMACEUTICS & PHARMACOKINETICS

2. It is commonly observed that there are several formulations of some drug, some drug, and similar dosage forms meant to be given by some route. So, the substitution of one product for another can be made as they are equally effective therapeutically. Objectives for Bioequivalence Studies If a new drug is intended to substitute for an approved medicinal product as a Pharmaceutical equivalent or alternative. The equivalence with that product should be shown or justified. Bioequivalence studies should be performed to ensure the clinical performance of such drug products

3. SOME IMPORTANT TERMS Equivalence: It is a relative term that compares drug products with respect to specific characteristics or function or to a definite set of standards. Chemical Equivalence: Indicates two or more drug products contain the same labelled chemical substance as an active ingredient. Pharmaceutical Equivalence: Indicates that two or more drug products are identical in strength, purity, quality, and content uniformity, and disintegration and dissolution characteristics. Bioequivalence: It is a relative term that denotes that the drug substance in two or more identical dosage forms reaches the systemic circulation at the same relative time to the same relative extent

4. Some important terms Therapeutic Bioequivalence: Indicates two or more drug products that contain some therapeutically active ingredient elicit identical pharmacological effects. DESIGN OF BIOEQUIVALENCE STUDIES The test and reference drug formulation must contain - Pharmaceutically equivalent drug - In the same dose strength - In a similar dosage form - Given by the same route of administration

5. Approval from the testing unit consists of both single and multiple dose studies. STUDY DESIGNS Fasting study: Did for immediate-release or modified-release oral dosage forms Male and female subjects are used Blood sampling is done at appropriate intervals to obtain the plasma-drug concentration time profile Subjects should be in a fasting condition (at least 10 hr before drug administration and 4 hr after administration)

6. 2) Food intervention study: Studies are conducted after a high-fat and high-calorie meal Subject is in fasting conditions for at least 10 hr before administration, and a meal is given 30 minutes before dosing ( no food is given for at least 4 hours after dosing) Done for the modified release dosage form and for the immediate release form if bioavailability is affected by food 3) Multiple dose (steady state) study : Done for oral extended-release (controlled-release) drug products Three consecutive C min measured on three consecutive days to determine steady state

7. 4) Cross over designs: Each subject receives a test and a reference drug product For example: Latin square crossover design Each formulation is administered just once to each subject and once in each study period Unlike a parallel design, all the subjects do not receive the same formulation at the same time in a given study period

8. Latin square crossover design for 6 or 12 subjects to compare three different formulations X, Y, Z Subject number Study period 1 Study period 2 Study period 3 1, 7 X Y Z 2, 8 Y Z X 3,9 Z X Y 4,10 X Z Y 5,11 Z Y X 6,12 Y X Z

9. Advantages: Minimize intersubject variability Minimize intrasubject variability Minimize variability due to time effect Drawbacks: The study takes a long time, as an appropriate washout period is essential

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