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 with meeting the country specific requirement. There are a lot of questions in mind once product is developed at plant like whether product fall in category of BE requirement, number of volunteers for BE study etc. This short course on bio-equivalence is introduced with the aim of providing a basic understanding to pharmaceutical companies to identifying a right partner for outsourcing. Sponsor can select a CRO by looking into their experience, study personnel, volunteer database, certification, meeting timelines and obviously cost. In next 10 chapters this course will cover about study design, regulatory & ethical requirement, pharmacokinetic & statistical aspects of BE studies.
Generally pharma companies face following queries if study is not conducted with authenticated CRO.
• Copy of license from the National Regulatory Authority for approved Bio-equivalence center for the study
• Details of the bio-equivalence center where study was conducted
• Copies of written and informed consent forms of the all subjects that took part in the study
• Log transformation of the concentration against the curve
• Copy of ethics committee authorization
• Protocol and detailed report for bio-analytical method validation including representative chromatography for the LC-MC/MS method used in the validation studies to determine the concentration of the analytes present in the plasma instead of the summary report provided
• Submit at least 20% of all chromatographs obtained for the subject who participated in the study
• Evidence of purchase of Innovator products used for the study
• Certificate of Analysis of the innovator products used for the study
Pharma companies should ensure that they should receive all the above mentioned documents as part of their report and support after submission of report to regulatory bodies for product registration. This course is also useful for all stakeholders participating in BE studies in terms of providing a complete crisp overview of all aspects.
Dr. Manoj Karwa
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