Why do we do bioequivalence studies?

Bioequivalence studies are used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two pharmaceutical products are said to be bioequivalent, then they would be expected to be the same for all intents and purposes.

What is bioequivalence study design?

A bioequivalence study compares the bioavailability between a test and a reference drug product in terms of the rate and extent of drug absorption. … The experimental design of a bioequivalence study is usually a crossover and rarely a parallel or a paired comparative.

Is bioequivalence study a clinical trial?

Bioequivalence studies are part of clinical research, where the systemic exposure of test and reference compounds are compared. Drug development is an expensive process with a high failure rate.

What is the difference between bioavailability study and bioequivalence study?

Bioavailability of a drug is the proportion that can reach the circulation in its unchanged form (API) and have an active effect. … The rate and extent of absorption is called as bioavailability. Bioequivalence is the comparison of bioavailability between two drug formulations.

What is the meaning of bioequivalence?

Bioequivalence is defined as ‘the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an …

What is bioequivalence study protocol?

Study Objective:  The objective for a bioequivalence study is that the drug bio availability from test and reference products are not statiscally different when administered to patients are subjects at same molar dose under similar experimental conditions.

What is bioequivalence Slideshare?

Bioequivalence :- It is a relative term which denotes that the drug substance in two or more identical dosage forms, reaches the systemic circulation at the same relative rate and to the same relative extent i.e. their plasma concentration-time profiles will be identical without significant statistical differences.

What is bioequivalence Mcq?

Explanation: Bioequivalence is a relative term which compares drug products with respect to specific characteristics or function to a defined set of standards. There are several types of bioequivalence such as chemical equivalence, pharmaceutic equivalence, bioequivalence, therapeutic equivalence.

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What is partial replicate study design?

A partial replicate design with repeating the reference product and scaling the bioequivalence for the reference variability are proposed for drugs with high within-subject variability. … This review also considers the mechanisms why drugs and drug products may exhibit large variability.

What does therapeutically equivalent mean?

FDA classifies as therapeutically equivalent those drug products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the identical active drug ingredient in the identical dosage form and route of …

What is bioequivalence FDA?

Bioequivalence, according to the FDA’s report, is the absence of a significant difference in the rate and extent that an active ingredient in pharmaceutical equivalents has contact with the site of the drug’s action. … The drug company must prove the generic is pharmaceutically equal to the name-brand version.

What is BA and BE in clinical trials?

BA/BE (Bioavailability & Bioequivalence) Studies. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

What phase are bioequivalence studies?

Bioavailability and bioequivalence studies are routinely conducted in a small number of subjects in Phase 1 CRUs and reported according to strict regulations.

How do you prove bioequivalence?

For oral drugs, bioequivalence is determined by comparing the relative bioavailability of the brand name drug versus the generic drug. There must be no more than a 20% difference between the AUC and Cmax of brand name versus generic products.

What makes a drug bioequivalent?

Two drug products are said to be bioequivalent if they are pharmaceutical equivalents (i.e., similar dosage forms made, perhaps, by different manufacturers) or pharmaceutical alternatives (i.e., different dosage forms) and if their rates and extents of absorption do not show a significant difference to which the active …

What is the meaning of pharmacodynamic?

Pharmacodynamics is the study of a drug’s molecular, biochemical, and physiologic effects or actions. It comes from the Greek words pharmakon meaning drug and dynamikos meaning power.

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What is Biopharmaceutics and Pharmacokinetics?

Abstract. Biopharmaceutics and pharmacokinetics are pharmaceutical disciplines useful to improve the outcome of drug therapies, assist drug product development, and establish pharmacokinetics-pharmacodynamics models and in vitro-in vivo correlations.

What is the acceptance criteria for bioequivalence study?

The currently accepted test is often called “bioequivalence”. The bioequivalence test states that we can conclude that two treatments are not different from one another if the 90% confidence interval of the ratio of a log-transformed exposure measure (AUC and/or Cmax) falls completely within the range 80-125%.

How long is bioequivalence study take?

Planned Duration: 9 days (approximately) including the wash-out period of 48 hours and the time between last blood sampling in the last period to the final examination tests.

What are the methods of assessing bioavailability?

Bioavailability is assessed by in vivo methodologies using gastrointestinal digestion, absorption, metabolism, tissue distribution, and bioactivity.

What the body does to drug?

Pharmacokinetics, sometimes described as what the body does to a drug, refers to the movement of drug into, through, and out of the body—the time course of its absorption.

What is in vitro bioequivalence study?

The increasing complexity of drug formulations is driving the application of in vitro bioequivalence (IVBE) testing – the process of using in vitro techniques to assess a test product’s bioavailability and bioequivalence to the reference listed drug (RLD) product – to help optimize and accelerate drug development.

What is bioequivalence PDF?

guidance, bioequivalence is defined as: “the absence of a significant difference in the rate and extent to which the active. ingredient or active moiety in pharmaceutical equivalents or pharmaceutical. alternatives becomes available at the site of drug action when administered at the.

Are generics bioequivalent?

In addition to being pharmaceutically equivalent, generic drugs must also be “bioequivalent” to the brand name drug. That means the generic drug will work in the body in the same way (same amount goes into the body within the same time frame) and be as safe and effective as the brand name drug.

Which of the following is the pharmacodynamic method of studying bioavailability?

Which of the following is the pharmacodynamics method of studying bioavailability? Explanation: Pharmacodynamic methods are a direct measurement of the drug effect on physiological processes as a function of time. The methods are acute pharmacologic response and therapeutic response.

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What is meant by elimination half life?

Half-life in the context of medical science typically refers to the elimination half-life. The definition of elimination half-life is the length of time required for the concentration of a particular substance (typically a drug) to decrease to half of its starting dose in the body.

Which form of the drug has highest bioavailability?

Explanation: Solutions are readily available. Thus having the highest bioavailability. Tablets take time to disintegrate. The order of decreasing bioavailability will be, solutions > emulsions > suspensions > capsules > tablets > coated tablets > enteric coated tablets>sustained released products.

Which design is adaptable for bioequivalence studies?

The most common design of bioequivalence studies is a two-sequence two-period two-treatment crossover design, where inclusion of 90% confidence intervals of pharmacokinetic metrics in a pre-defined acceptance range has to be shown.

What is intra subject variability in bioequivalence?

The most important variation in crossover designs is the intrasubject or within-subject variance, which is the variation, exhibited by a single person when given the same dose of a drug over repeated administrations. The magnitude of the intrasubject variance depends on the pharmacokinetics of the drug itself.

What is replicate design?

Replicated Designs are designs in which all or almost all of the main factor design is repeated a few or several times. Design Replicates allow an estimate of variance for each run of the main factor design, thereby allowing for an analysis of variation over the full range of the experiment.