A STUDY ABOUT BIOEQUIVALENCE PROTOCOL

About author:
Chinmaya Keshari Sahoo*
Research Scholar, Dept. of Pharmaceutics,
OUCT, Osmania University,A.P, India
*e-mail: [email protected]

INTRODUCTION:
The comparative bioavailability assessment of two or more formulations of the same active ingredient to be administered by the same route is termed as bioequivalence.Bioequivalence studies compare both the rate and extent of absorption of various multisource  drug  formulations  with  the  innovator (reference) product,on the basis that if two formulations exhibit similar drug concentration‐time profiles  in the  blood they should exhibit similar therapeutic effects Bioequivalence studies  provide  quality control  tool  to monitor manufacturing changes & production.
Key words: Bioequivalence, Innovator product, quality control tool
DESCRIPTION:
Two drug products are usually regarded to be bioequivalent if they happen to be pharmaceutical equivalents or alternatives and they exhibit the same bioavailability after being administered with the same molar dose. It has been duly proved that two products are pronounced to be bioequivalent only when they explicitly demonstrate similar rate(speed) of drug release and degree of drug release pattern. To establish bioequivalence the calculated 90% confidence interval for AUC (Area Under Curve) and Cmax should fall within the bioequivalence range usually 80-125%.In boarder prospective any elaborated bioequivalence study is invariably geared by a well planned study protocol must comprise the following essential aspects namely
1. Title-it specifically includes
Principal investigator or study  director
Nomenclature of project, protocol number and date of commencement
2. Study Objective-it consists of major aspects pertaining to the engaged   study objectives
3. Study Design-it is the most critical aspect of the entire study undertaken and consists of
Design, Dosage forms(or Drug Products)
Test product
Reference product
Dosage regimen
Sample collection schedule
Housing of volunteers
Fasting and meal schedule
Analytical method selected
4. Study Population-it forms an important aspect as well
Subjects(or volunteers)
Selection of subject
Medical history of subject(S)
Physical check up
Clinical laboratory tests
Inclusion and exclusion criteria
Limitations during investigative study
5. Clinical Methodologies-to provide valuable information
Drug and dosage administration profile
Biological sampling modes
Handling of biological samples
6. Ethical Considerations-to cater for sufficient preventive measures
Institutional review board
Informed consent of subject(S)
Critical indications for withdrawal of subjects
Adverse drug reactions
Emergency procedures
7. Facilities Provided-to include enough required facilities at the testing centre as per  norms
8. Analysis Presentation of Data-to get authentic and dependable results
Validation adopted analytical method
Statistical methods used
Statistical treatment of data analysis of variance (ANOVA)
Format of data
9. Appendix –to provide all other allied information required
Conclusion:  
The current review gives idea about bioequivalence protocol