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DC Field | Value | Language |
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dc.date.accessioned | 2021-06-24T09:43:33Z | - |
dc.date.available | 2021-06-24T09:43:33Z | - |
dc.date.issued | 2012 | - |
dc.identifier.citation | Aquilina, C. (2012). Compliance with the new European bioequivalence guideline : development of a tool for assessment (Master’s dissertation). | en_GB |
dc.identifier.uri | https://www.um.edu.mt/library/oar/handle/123456789/77692 | - |
dc.description | M.SC.PHARMACOLOGY | en_GB |
dc.description.abstract | Many pharmaceutical companies invest in the development of non-originator medicinal products owing to the financial remuneration it offers. These medicinal products do not require the conduct of non-clinical and clinical studies if bioequivalence to the originator can be proven. This reduces ethical issues, costs and work to the pharmaceutical company and regulators. It also increases availability of the drug and reduces stock issues when the originator is unavailable thus aiding in public health and national health services. Bioequivalence studies submitted in support of a non-originator product's marketing authorisation application must be carried out in accordance with the current bioequivalence guideline unless adequately justified. Compliance to such a guideline is of paramount importance as justification for deviation from the guideline may lead to subjective interpretation thus affecting approvability of the product. | en_GB |
dc.language.iso | en | en_GB |
dc.rights | info:eu-repo/semantics/restrictedAccess | en_GB |
dc.subject | Pharmaceutical industry | en_GB |
dc.subject | Drugs | en_GB |
dc.subject | Drugs -- Therapeutic equivalency | en_GB |
dc.title | Compliance with the new European bioequivalence guideline : development of a tool for assessment | en_GB |
dc.type | masterThesis | en_GB |
dc.rights.holder | The copyright of this work belongs to the author(s)/publisher. The rights of this work are as defined by the appropriate Copyright Legislation or as modified by any successive legislation. Users may access this work and can make use of the information contained in accordance with the Copyright Legislation provided that the author must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the prior permission of the copyright holder. | en_GB |
dc.publisher.institution | University of Malta | en_GB |
dc.publisher.department | Faculty of Medicine and Surgery. Department of Clinical Pharmacology and Therapeutics | en_GB |
dc.description.reviewed | N/A | en_GB |
dc.contributor.creator | Aquilina, Cheryl (2012) | - |
Appears in Collections: | Dissertations - FacM&S - 2012 Dissertations - FacM&SCPT - 2012 |
Files in This Item:
File | Description | Size | Format | |
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M.SC.PHARMACOLOGY_Aquilina_Cheryl_2012.pdf Restricted Access | 24.77 MB | Adobe PDF | View/Open Request a copy |
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