EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-01-29 16:52 (395 d 03:21 ago) – Posting: # 21096
Views: 2,808

Hi John,

» Need some help with running studies in Europe. If I want to run a PK study under each of the two scenarios:

First of all: Are you talking about generic application (Directive 2001/83/EC, Article 10(1))? If yes, see below. Otherwise, please provide more details.

» 1. With a drug that is not approved in Europe …

Showstopper: “… reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, as amended.”

» 2. With a drug that is approved in Europe but at a higher total daily dose than that on the label.

Theoretically possible (Section 4.1.6 of the BE GL): “… if problems of sensitivity of the analytical method preclude sufficiently precise plasma concentration measurements after single dose administration of the highest strength, a higher dose may be selected (preferably using multiple tablets of the highest strength). The selected dose may be higher than the highest therapeutic dose provided that this single dose is well tolerated in healthy volunteers and that there are no absorption or solubility limitations at this dose.

» What do I need to file?

You need a very (very!) good justification.

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Helmut Schütz
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