RAC Drugs Final Exam 2024 | 40
Questions with 100% Correct Answers |
Verified | Latest Update | Graded A+
What information must appear in braille? - ✔✔Product name on pack
T or F. European Scientific guidelines do not have legal force - ✔✔True
Purpose of ICH? - ✔✔To discuss and establish common guidelines for
safe, effective, and high quality medicines for ICH regions
What method is used for stability retest period? - ✔✔Long term data and case
by case assessment
, FOB - ✔✔Follow on Biologics or biosimilars
ICH Q10 - ✔✔Pharmaceutical Quality System
Biosimilar - ✔✔New versions of existing biologics whose patents have
expired. Fobs or SEBs
SEB - ✔✔Subsequent Entry Biologic (Canada)
monoclonal antibodies - ✔✔Structurally complex substances that can locate
and bind to specific molecules
Essential Requirements for permanently implanted active device - ✔✔90/385/EEC
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