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Bioeqivqlqnce studies

This document discusses bioequivalence and its assessment. It defines bioequivalence as two identical drug products reaching systemic circulation at the same rate and extent. Bioequivalence can be assessed through in vivo and in vitro studies. In vivo studies measure absorption rate, percentage absorbed, and pharmacokinetic parameters while in vitro studies examine dissolution rate and percentage dissolved. Parameters like Cmax and AUC are used to determine if products are bioequivalent. Bioequivalence studies allow generic drugs to be approved without new clinical trials, reducing costs.

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BY NEERAJ PANDEY M PHARM (PHARMACEUTICS) RITM LUCKNOW.
 EQUIVALENCE.  BIOEQUIVALANCE.  FLOW CHART.  GRAPH  TYPES OF BIOEQUIVALENCE.  IN VIVO STUDIES.  IN VITRO STUDIES.  PARAMETER OF CORRELATION.  METHOD TO ASESS BIOEQUIVALANCE.  ADVANTAGE.  DISADVANTAGE.  CONCLUSION.
 Equivalence is a relative term which compares drug product with respect to specific characteristic or function.  Types of equivalence i. Chemical equivalence. ii. Pharmaceutical equivalence. iii. Bio equivalence. iv. Therapeutic equivalence.
 Bioequivalence refers to the drug substances in two or more identical dosage forms, reaches the systemic circulation at the same rate and same relative extent.  Example- The plasma concentration-time profile will be identical without significant differences.
 IN VIVO STUDIES  IN VITRO STUDIES
 Oral immediate release product with systemic action. i. Narrow therapeutic response. ii. Absorption<70% or nonlinear kinetics, pre systemic elimination >70%. iii. Documented evidence for bioavailability problem. iv. Unfavorable physiochemical properties e.g. low solubility, instability etc. v. No relevant data available.  Non oral immediate release product.  Modified release product with oral action.
o The drug product differ only in strength of active substance it contain following condition same I. Pharmacokinetics are linear. II. The qualitative composition is same. III. The ration between active substance and excipient is same. IV. Both product are made by same manufacturer at same manufacturing site.
V- A bioavailability or bioequivalence study has been performed with the original product Vi- In vitro dissolution rate is same o The product is slightly reformulated or the manufacturing method has been slightly modified. o The drug product meet following requirement i. Solution or solubilized form. ii. Active ingredients in same concentration as approved drug. iii. Contain no excipients known to significantly effect absorption of active ingredients.
IN VIVO STUDIES IN VITRO STUDIES  Absorption Rate  Percentage Drug Absorbed  C max serum drug concentration  Dissolution Rate  Percentage Drug Dissolved  Studies Performed In Laboratory
 Pharmacokinetic method  Plasma level-time studies. i. Trapezoidal method ii. Cut and weigh method  Urinary excretion studies.  Pharmacodynamics method. I. Acute pharmacological response. II. Therapeutic Response’
 Minimize the effect of inter subject variability.  It minimize the carryover effect.  Require less no of subject to get meaningful result.
 Require longer time to complete the studies.  Increase in period leads to high subject dropouts.  Medical ethics does not allow too many trials on a subject continuously for a longer time.
 Bioequivalence is used mainly for the generic drug for reducing its cost because if the drug is only proved to be equivalent to its brand previously approved drug then there is no need to perform the clinical trial and it is also used to minimize difference between batches of same drug.
Bioeqivqlqnce studies