The bioequivalence of generic medicines leading to referrals in the EU: the impact of guidance

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dc.contributor.author Tossavainen-Nikki, Linda
dc.date.accessioned 2020-06-08T18:31:59Z
dc.date.available 2020-06-08T18:31:59Z
dc.date.issued 2020-05
dc.identifier.uri http://hdl.handle.net/10138/315920
dc.description Teollisuusfarmasian erikoistumiskoulutus Projektityö fi
dc.description.abstract Subject of this study was referrals in marketing authorisation procedures of medicines, in particular related with bioequivalence studies. The focus was in bioequivalence studies of the generic medicines. Referrals are processes in which controversial questions related with marketing authorisations are solved. Bioequivalence studies are required from the generic medicinal products against the original product. Purpose of the study was to find out if the latest renewed bioequivalence guidance from the year 2010 has had an influence in the number of referrals or the reasons for referral. Research material for the case study has been collected mainly from the European Medicines Agency’s public files where information of the referrals can be found via public assessment reports and other public documents and statistics. A list of all the referrals in which the main reason for referral was related with the bioequivalence studies, altogether thirty eight (38) cases, was created and the product list was further investigated against the updated bioequivalence guidance and categorised according to the year of the referral as well as the detailed description of the reason for referral. As a conclusion of the study, one major group of referrals related with bioequivalence study, was noted: the fed and fasting conditions during bioequivalence studies. The bioequivalence guidance from the year 2010 included improved guidance regarding the fed and fasting conditions. Some medicinal products have a different bioavailability depending weather they have been taken with or without meal. Usually fasting conditions is the most sensitive condition to study bioequivalence. Recommendations of the SPC (Summary of Product Characteristics) of the original medicine are followed when choosing fed or fasting conditions for the study. There was found a connection with the rise of the referral cases was and the fast increase of the generic marketing authorisation applications from year 2005 to year 2010. One reason for the number of generics was the generic substitution. However, it was noted that number of referrals did not increased the same amount and share of the bioequivalence referrals was smaller after introducing the new bioequivalence guideline. In this study, also referrals regarding Good Clinical Practise (GCP) were briefly reviewed since some bioequivalence related referrals dealt with deficiencies in the Contract Research Organisations (CRO’s). Authorities are responsible for inspecting these facilities in order to guarantee the reliability of the clinical studies as well as safety and efficacy of the studies. However, there were only seven referrals regarding CRO’s and therefore it was not possible to make deep conclusions based on these cases due to the narrow material. However, in most of these referral cases the outcome was that there were not such neglects which would have been criteria for suspension of the marketing authorisations. fi
dc.language.iso en fi
dc.subject bioequivalence fi
dc.subject referral fi
dc.subject generic fi
dc.subject Guideline on the Investigation of Bioequivalence fi
dc.title The bioequivalence of generic medicines leading to referrals in the EU: the impact of guidance fi
dc.type Opinnäyte fi

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