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How many drugs contain lactation specific information?

Terrmin

HT24

Beskrivning

Aim
To evaluate whether the drugs approved in the EU have lactation specific information.
Background
There is still a lack of information on taking drugs during lactation. Larger databases which have collated data suggest that more than 50% of approved drugs lack information on use during lactation. The interest to lessen this information gap is increased, and regulation has been changing. Has this changed the recommendations, the number of studies performed and the species the studies were performed on?
Methods
Get up to date with EU regulation, what are the requirements for approval? Extract lactation specific information from SPCs of currently approved drugs. Literature search for pharmacokinetic studies to confirm these results.
Student interests and traits
Lactation. EU and Swedish legislation. Detail focussed, careful and orderly. Good excel skills are a must.
Note
The student will work at BMC. The working and writing language will be English.
Contact / Supervisor
Ilse Dubbelboer, ilse.dubbelboer@uu.se
Researcher, Pharmaceutical Biosciences, Uppsala University

Huvudområde

Farmaceutisk vetenskap

Ämne

Biofarmaci

Typ

Litteraturstudie

Företag

Uppsala University

Ort/Plats

Uppsala

Handledarens namn

Ilse Dubberboer

Handledarens e-post

ilse.dubberboer@uu.se

Institution

Institutionen för farmaceutisk biovetenskap

Program

Apotekarprogrammet

Kurs

Fördjupningsprojekt i biofarmaci 30 hp - 3FG008

Omfattning/hp

30hp

Hur många studenter kan antagas för detta projekt?

1

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