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Parameters to evaluate Bioequivalence

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Parameters to evaluate Bioequivalence Presented by: Vinitha Nair M.Sc Bio-analytical Sciences Part 2

Contents:

Contents Bioequivalence Bioequivalence: Background Goals of BE Pharmaceutical Equivalents Pharmaceutical E quivalence Pharmaceutical Alternatives Therapeutic Equivalence Interchangeable Pharmaceutical Products Parameters Concept of “Half Life” References

Bioequivalence:

Bioequivalence Two medicinal products are bioequivalents if they are pharmaceutical equivalents or alternatives and if their bioavailabilities (rate and extent) after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, will be essential the same.

Bioequivalence: Background:

Bioequivalence: Background

Goals of BE:

Goals of BE Bioequivalen c e studies focus on changes to the dosage form process after pivotal studies commence to ensure product on the market is comparable to that upon which the efficacy is based .

Pharmaceutical Equivalents:

7 Pharmaceutical Equivalents C ontain the same amount of the same active substance in the same dosage form. M eet the same or comparable standards. I ntended to be administered by the same route . Pharmaceutical equivalence by itself does not necessarily imply therapeutic equivalence

Pharmaceutical Equivalence:

Pharmaceutical E quivalence Reference Test Pharmaceutical Equivalent Products Possible Differences Drug particle size, .. Excipients Manufacturing process Equipment Site of manufacture Batch size …. Documented Bioequivalence = Therapeutic Equivalence (Note: Generally, same dissolution specifications)

Pharmaceutical Alternatives :

Pharmaceutical Alternatives identical therapeutic moiety, or its precursor not necessarily the same: salt or ester of the therapeutic moiety amount dosage form

Therapeutic Equivalence:

Therapeutic E quivalence Pharmaceutically equivalent T heir effects, with respect to both efficacy and safety, will be essentially the same as derived from appropriate studies

Interchangeable Pharmaceutical Products:

Interchangeable Pharmaceutical P roducts If a product is demonstrated to be therapeutically equivalent to a reference product, then the products are considered interchangeable.

PowerPoint Presentation:

Concept of interchangeability includes the equivalence of the dosage form as well as for the indications and instructions for use . Therapeutic equivalence of a multiscource product can be assured when the multiscource product is both pharmaceutically equivalent/alternative and bioequivalent . TE = PE + BE

Parameters :

Parameters Peak plasma concentration ( Cmax ) Time of peak plasma concentration ( Tmax ) Area under curve(AUC) Half life (T1/2) These are following parameters:

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AUC : area under the concentration-time curve  measure of the extent of bioavailability C max : the observed maximum concentration of drug  measure of both the rate of absorption and the extent of bioavailability ( µg/ mL or ng / mL ) T max : the time after administration of drug at which C max is observed  measure of the rate of absorption ( minutes or hours) Note that bioequivalence standards are applied to the pharmacokinetic parameters AUC and Cmax but not to Tmax .

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Pharmacokinetic Studies Key Measurements AUC Area under the concentration- time curve C max Maximum concentration A difference of greater than 20% in C max or the AUC represents a significant difference between the test and reference compounds T max Time to maximum concentration Test Compound Reference Compound Time(Hr) Plasma Concentration (µg\ml) C max T max AUC 9/25/2013 15

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To establish BE: The calculated 90% CI for C max & AUC , should fall within range: 80-125% ( Range of Bioequivalence ) Non-parametric data 90% CI for T max should lie within clinical acceptable range

Concept of “Half Life”:

Concept of “Half Life” ½ life = how much time it takes for blood levels of drug to decrease to half of what it was at equilibrium There are really two kinds of ½ life… “ distribution ” ½ life = when plasma levels fall to half what they were at equilibrium due to distribution to/storage in body’s tissue reservoirs “ elimination ” ½ life = when plasma levels fall to half what they were at equilibrium due to drug being metabolized and eliminated It is usually the elimination ½ life that is used to determine dosing schedules, to decide when it is safe to put patients on a new drug

References:

References www.authorstream.com/.../sanketrekhawar111-466277-bioequivalence‎ www.thaifda.com/editor/data/files/.../ BABE_concept www.icmcc.org/ppt/roy.ppt‎ www.powershow.com www.fda.gov/ohrms/dockets/ac/04/slides/4034S2_12_Lionberger.ppt www.fda.gov/ohrms/dockets/ac/04/slides/4034S2_07_Haidar.ppt‎

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