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Bioequivalence


As per available reports about 43 relevant Journals, 38 Conferences, 3 Workshops are presently dedicated exclusively to bioequivalence and about 335 articles are being published on bioequivalence.

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. Suitable methods for assessing equivalence are

OMICS International Organizes 1000+ Global Events Every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 700+ Open access journals which contains over 100000 eminent personalities, reputed scientists as editorial board and organizing committee members. The conference series website will provide you list and details about the conference organize worldwide.  

Scope and Importance:

Bioequivalence Conference provides the scope for opportunities to learn progressed by international scientists and academicians. So many symposiums have been conducted and are to be organized all across the globe focusing on the significance of Bioequivalence Innovations, Therapeutic Possibilities and Technological Challenges is going to be organized which will focus on Bio equivalence.

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Birkett (2003) defined bioequivalence by stating that, "two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same. Pharmaceutical equivalence implies the same amount of the same active substance(s), in the same dosage form, for the same route of administration and meeting the same or comparable standards."
The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
Different approaches for establishing equivalence are PD studies, Clinical studies, in vitro methods. Therapeutic equivalence of a multiscource product can be assured when the multiscource product is both pharmaceutically equivalent/alternative and bioequivalent.

Therapeutic bioequivalence:
i. Pharmaceutically equivalent
ii. Same safety and efficacy profiles after administration of same dose
In determining bioequivalence, for example, between two products such as a commercially-available Brand product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study to volunteer subjects, generally healthy individuals but occasionally in patients. Serum/plasma samples are obtained at regular intervals and assayed for parent drug (or occasionally metabolite) concentration. Occasionally, blood concentration levels are neither feasible nor possible to compare the two products (e.g. inhaled corticosteroids), then pharmacodynamic endpoints rather than pharmacokinetic endpoints are used for comparison. For a pharmacokinetic comparison, the plasma concentration data are used to assess key pharmacokinetic parameters such as area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), and absorption lag time (tlag). Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics.
 

Market Analysis:

An overview of the global market bioequivalence of drugs, including coverage of therapeutics such as antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

International symposium and workshops

List of Best International Conferences:

  1. 7th Bioavailability and Bioequivalence: BA/BE Studies Summit
    August 29-31, 2016 Atlanta, USA
  2. 8th  Pharmaceutics and Novel Drug Delivery Systems Conference 
    March 07-09, 2016 Madrid, Spain
  3. Industrial Pharmacy Conference
    April 28-29, 2016 Dubai, UAE
  4. 5th Global Pharmacovigilance Summit 
    April 25-27, 2016 Dubai, UAE
  5. Medical Writing and Healthcare Communications Conference
    April 28-29, 2016 Dubai, UAE
  6. 2nd Pharmacology and Ethnopharmacology Conference
    May 02-04, 2016 Chicago, USA
  7. 4th European Pharma Congress
    June 13-15, 2016 Berlin, Germany
  8. American Pharma Expo
    June 20-22,2016 New Orleans, USA
  9. 7th Annual Pharma Summit
    June 20-22, 2016 New Orleans, USA
  10. 6th Pharmacovigilance Conference Congress
    August 01-03, 2016 Toronto, Canada
  11. 3rd World Congress on Pharmacology
    August 08-10, 2016 Birmingham, UK
  12. 2nd Clinical Trials Conference 
    August 22-24, 2016 Philadelphia, USA
  13. 2nd Drug Discovery & Designing Conference 
    Oct 31-Nov 02, 2016 Istanbul, Turkey
  14. ICPSP 2016: 18th International Conference on Pharmaceutical Sciences and Pharmacology Jan 21-22,2016 Paris, France
  15. 29th Annual Pharmacokinetics for Pharmaceutical Scientist 29 Feb – 4 March 2016 San Francisco, CA
  16. JP Morgan Annual Healthcare Conference January, 2016
  17. ASCPT Annual Meeting San Diego, CA Mar 8-12, 2016  
  18. 29th Orphan Drugs, Collaborations and Market Access Congress San Diego, United States of America
  19. 11th Drug Discovery India 2014 Mumbai, India
  20. 27th Re-Entering Antibacterial Drug Development Summit Boston, United States of America

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This page was last updated on 11th Sep, 2015

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