May 2011

Established in 2002. Total Professional Approach. Professionals handling assignments for Specific Sectors/Industy with rich experience & background. Working with Reputed Clients having Top Ranking in threir Sectors

Post: Executive, Officer-Dispensing, Officer/Sr. Officer-QC

TYD IDeas is a HR Consultancy with varied projects in Training, HR services. They are currently looking out for Medical Represenatatives for one of their Clients. Kindly send in your resumes since the postions are across India.

Post: Medical Representative

About Author: 1. Shah Dhaval D., M.Pharm-II Semester, Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India
2. Sharma Anil, M.Pharm, H.O.D. Quality Assurance Department, Gyan Vihar School of Pharmacy, Jaipur, India

Reference ID: PHARMATUTOR-ART-1050

Abstract
Generic pharmaceutical products need to confirm to the same standard of quality, efficacy and safety as required of the originator’s (innovator) product. Spefically, the generic product should be therapeutically equivalent and interchangable with the reference product. Testing the bioequivalence between a test product pharmacetically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmacokinetic study with a limited no of subjects is one way of demonstrating therapeutic equivalence. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. This article provides the information about important aspect involved in bioequivalence and regulatory requirment for bioequivalence study.

GPAT-2011 PAPER

{Answers are on the end page of question Paper}