Pharmacy Practice for Final Year B.Pharmacy Sem-VII, As per PCI Syllabus Investigational use of drugs

2. Developing a chemical from the status of an
interesting or unique pharmacological entity to
that of a useful therapeutic tool involves the
efforts of many individuals.

3. •
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•
•
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Safe
Effective
Need
Potential benefits
Side effects
Treatment options
Etc

4. Research or Investigational Drugs are those
compunds or mixtures which have not been released
by the Food And Drug Administration for general
distribution amd use.

5. ① Class A:- Drugs that are in Preliminary
experimental stage.
② Class B:- Drugs which have passed through the
preliminary research stage.
③ Class C:- Drugs approved or passed by the FDA
for commercial distribution.
④ Class D:- Drugs are preparations which have
been accepted for use in the hospital and are
listed in the hospital formulary.

6. Another Simole classification which can be
adapted to any hospital pharmacy operations:
① General
② Conditional
③ Investigational

7. •
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The copy of Research Protocol should be kept
in Pharmacy after its approval from Institutional
Review Committee.
Prepare "Investigational Drug Data
Sheet".

8. ① Assisting in the development of the study
design
② Acting as an impartial collaborator
③ Collecting,storing and distributing essential
information concerning the drugs being studied
④ Packing and labeling investigational drugs in
multiple or unit dose containers
⑤ Preparing dosage forms
⑥ Dispensing of investigational drugs to both
inpatients and outpatients.

9. •
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The Generic Drugs Advisory Committee is to
advice on the safty and effctiveness of human
generic drug products for use in treating"a
broad spectrum of human diseases."
The Drug Abuse Advisory Committee,with a
broad charge, advises the FDA
Commissioner on "the scientific and medical
evaluation of all information.

10. •
•
The FDA regulates more than
1,50,000 marketed drugs and medical
devices.
At any time, nearly 3,000vinvestigational new
drugs are being developed.

11. REFERENCES:-
1. A Text book of Pharmacy Practice by the author Sourabh
Kosey Nirali Prakashan. Page No.20.1-20.8
2. A Text book of Pharmacy Practice by the author Dr. Sachin
V. Tembhurne, Dr. Ashwini R. Madgulkar, Dr. Virendra S.
Ligade Nirali Prakashan. Page No.20.1-20.6
3. www.Google.com