Lecture 12: Supply of Unapproved Therapeutic Goods Flashcards
1
Q
Control of supply of therapeutic goods?
A
pre-market evaluation and approval
licensing and certification of manufacturers
post-market surveillance
2
Q
Ways to get devices not on ARTG?
A
clinical trials
SAS
authorised prescribers
importation
3
Q
Clinical trials definition
A
Investigation to identify:
effects
adverse reactions
ADME, safety and efficacy
4
Q
Classification of CTs
A
Pre-clinical short term animal Pre-clinical long term animal phase I phase II phase III phase IV
5
Q
Explain the CTN scheme
A
-
6
Q
Explain the CTX scheme
A
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