B.E. Study
Bio-Equivalence
Introduction
Bioequivalence study data has long been a standard part of the dossiers for approval of generic products in all regulated markets, which includes the highly developed countries like United States of America, Europe, Japan, Australia and South Africa. Even the rest of world (ROW) markets are now asking for bioequivalence data to be submitted as part of the regulatory dossiers for approval of the generic products.
Looking at bioequivalence studies beyond just being a regulatory requirement, bioequivalence studies which are conducted properly can help establish the product as a reputed brand because the therapeutic efficacy of a well-developed and bioequivalent product will be far better than a bio-in equivalent product. So bioequivalence studies not only help you get the regulatory approvals to enter a market, a bioequivalent product will also help establish the brand value and reputation of the company in that market.
A bioequivalence study establishes that the rate and extent of the drug being absorbed into the system is same to that of the innovator product with which extensive clinical trials have been conducted to establish as therapeutic efficacy and safety profile by the innovator company. For most molecules the pharmacodynamics are closely linked to the pharmacokinetic profile (PK PD correlation) thus if the pharmacokinetic profile is matched with that of the innovator product, It is expected to have the same efficacy and safety profile.
This gives the generic manufacturers a huge saving in the costs which goes into developing new drug by taking it through the various stages of preclinical and clinical evaluation to establish safety and efficacy.
Submitting a bioequivalence study along with regulatory dossier is one of the requirements for product registration in most of the countries and pharma companies always look for a right partner who can help them in conduct of these studies in cost effective and timely manner
Introduction
Bioequivalence study data has long been a standard part of the dossiers for approval of generic products in all regulated markets, which includes the highly developed countries like United States of America, Europe, Japan, Australia and South Africa. Even the rest of world (ROW) markets are now asking for bioequivalence data to be submitted as part of the regulatory dossiers for approval of the generic products.
Looking at bioequivalence studies beyond just being a regulatory requirement, bioequivalence studies which are conducted properly can help establish the product as a reputed brand because the therapeutic efficacy of a well-developed and bioequivalent product will be far better than a bio-in equivalent product. So bioequivalence studies not only help you get the regulatory approvals to enter a market, a bioequivalent product will also help establish the brand value and reputation of the company in that market.
A bioequivalence study establishes that the rate and extent of the drug being absorbed into the system is same to that of the innovator product with which extensive clinical trials have been conducted to establish as therapeutic efficacy and safety profile by the innovator company. For most molecules the pharmacodynamics are closely linked to the pharmacokinetic profile (PK PD correlation) thus if the pharmacokinetic profile is matched with that of the innovator product, It is expected to have the same efficacy and safety profile.
This gives the generic manufacturers a huge saving in the costs which goes into developing new drug by taking it through the various stages of preclinical and clinical evaluation to establish safety and efficacy.
Submitting a bioequivalence study along with regulatory dossier is one of the requirements for product registration in most of the countries and pharma companies always look for a right partner who can help them in conduct of these studies in cost effective and timely manner