125459 -

Figyelem! A Videa nem kér banki adatokat sem a regisztráció létrehozásakor, sem a Videa.hu oldalon található tartalom megtekintésekor, illetve ezen funkciók igénybevétele nem igényel díjfizetést. Kérjük, hogy ha erre vonatkozó üzenetet kap a Videa felületén, ne kattintson a benne szereplő hivatkozásokra, és ne adjon meg adatokat!

125459 -

The guideline, officially titled , provides a framework for non-clinical studies required before a gene therapy can be used in human clinical trials. Guide to EMA Guideline 125459

This document outlines the essential safety and efficacy data that developers must generate during the "non-clinical" (animal or lab) phase to justify moving into human subjects.

: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy.

: Checking if the patient might "shed" or spread the virus/vector through secretions.

: Assessing the risk of "insertional mutagenesis"—where the therapy might accidentally interfere with the patient's existing DNA.

The guideline, officially titled , provides a framework for non-clinical studies required before a gene therapy can be used in human clinical trials. Guide to EMA Guideline 125459

This document outlines the essential safety and efficacy data that developers must generate during the "non-clinical" (animal or lab) phase to justify moving into human subjects.

: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy.

: Checking if the patient might "shed" or spread the virus/vector through secretions.

: Assessing the risk of "insertional mutagenesis"—where the therapy might accidentally interfere with the patient's existing DNA.