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Biostudy Management
- Two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailability after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, are the same.
- Bioequivalence studies (also known as biostudies) are a necessary part of proving essential similarity for generic applications. A biostudy demonstrates if slight differences in formulation, method of manufacture or source of active ingredients have an impact on the rate and extent of absorption.
- Ivowen Limited have extensive experience in the field of biostudy management. We can:
- Source a Contract Research Organisation (CRO) to carry out either or both the clinical and analytical aspects of a biostudy,
- Carry out pre-study audits of the CRO,
- Provide advice on and review biostudy designs,
- Monitor studies to ensure Good Clinical Practise (GCP) compliance,
- Review of final reports.
- All of the above are carried out in accordance with current GCP as per the ICH guidelines.
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