Question 24: Please prepare a draft of the IB for the imaginary drug Happymycin that would treat Mood Disorders (Depressions) . Please include all appropriate parts according to ICHGCP?
Please find below the draft of the investigator’s brochure for the imaginary drug Happymycin.
Generic Name(s): Gladmycin
Trade Name(s) Happymycin
Edition Number: 30798
Release Date: 01 December, 2008
TABLE OF CONTENTS OF INVESTIGATOR’S BROCHURE
Happymycin is prescribed for the treatment of schizophrenia, a mental disorder marked by delusions (false beliefs), hallucinations, disrupted thinking, and loss of contact with reality. It is also used for the short-term treatment of mania associated with bipolar disorder.
Introduction Happymycin is the first in a new class of antipsychotic medications. Researchers believe that it works by diminishing the action of dopamine and serotonin, two of the brain’s chief chemical messengers.
Happymycin may cause tardive dyskinesia, a condition characterized by uncontrollable muscle spasms and twitches in the face and body. This problem can be permanent, and appears to be most common among older adults, especially women.
4. Physical, Chemical, and Pharmaceutical Properties and Formulation
5. Nonclinical Studies
5.1 Nonclinical Pharmacology
5.2 Pharmacokinetics and Product Metabolism in Animals
6 Effects in Humans
6.1 Pharmacokinetics and Product Metabolism in Humans
6.2 Safety and Efficacy
6.3 Marketing Experience
7 Summary of Data and Guidance for the Investigator
NB: References on 1. Publications
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