A Review on Importance of CRO in the management of Bioavailability and Bioequivalence study

  • Unique Paper ID: 167005
  • Volume: 11
  • Issue: 3
  • PageNo: 134-140
  • Abstract:
  • In pharmaceutical industry, outsourcing is becoming more commonplace. The practice of contracting out corporate operations and procedures to outside parties, known as outsourcing. There are numerous reasons why a company would decide to outsource specific operation, ranging from cost savings and efficiency advantages to a stronger competitive advantage. Enhanced concentration on business operations, heightened productivity, cost management, improved quality, and a stronger competitive edge are just a few of the acknowledged advantages of outsourcing. Pharmaceutical research services are rendered by contract research organizations (CROs) to biotechnology and pharmaceutical industries. CROs serve as connection between the clinical trial's sponsor, the party hiring the services, and other participants. Ensuring therapeutic equivalency between pharmaceutically equivalent test medications, generic or reference drugs is the goal of bioequivalence-bioavailability investigations. Bioanalytical studies, clinical study design, clinical protocol development, clinical site selection, clinical monitoring, data management, project management, FDA/regulatory consultation are representative services that outsourced for Bioequivalence-Bioavailability studies.

Copyright & License

Copyright © 2025 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{167005,
        author = {shilpa chapekar and poonam pardhi and shubhangi raut and vishakha oimbe and darshana shende},
        title = {A Review on Importance of CRO in the management of Bioavailability and Bioequivalence study},
        journal = {International Journal of Innovative Research in Technology},
        year = {2024},
        volume = {11},
        number = {3},
        pages = {134-140},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=167005},
        abstract = {In pharmaceutical industry, outsourcing is becoming more commonplace. The practice of contracting out corporate operations and procedures to outside parties, known as outsourcing. There are numerous reasons why a company would decide to outsource specific operation, ranging from cost savings and efficiency advantages to a stronger competitive advantage. Enhanced concentration on business operations, heightened productivity, cost management, improved quality, and a stronger competitive edge are just a few of the acknowledged advantages of outsourcing. Pharmaceutical research services are rendered by contract research organizations (CROs) to biotechnology and pharmaceutical industries. CROs serve as connection between the clinical trial's sponsor, the party hiring the services, and other participants. Ensuring therapeutic equivalency between pharmaceutically equivalent test medications, generic or reference drugs is the goal of bioequivalence-bioavailability investigations. Bioanalytical studies, clinical study design, clinical protocol development, clinical site selection, clinical monitoring, data management, project management, FDA/regulatory consultation are representative services that outsourced for Bioequivalence-Bioavailability studies.},
        keywords = {Outsourcing, CRO, Bioavailability, Bioequivalence.},
        month = {August},
        }

Cite This Article

  • ISSN: 2349-6002
  • Volume: 11
  • Issue: 3
  • PageNo: 134-140

A Review on Importance of CRO in the management of Bioavailability and Bioequivalence study

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