Investigational use of drugs

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

1. Investigational Use Of Drugs Prepared By:Ms.Mali S.M. Asst.Professor Subject: Pharmacy Practice Sahyadri College of Pharmacy, Methwade.

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. • • • • • • • Safe E ffe c t i v e 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. • • 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. • • 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:- A Text book of Pharmacy Practice by the author Sourabh Kosey Nirali Prakashan . Page No.20.1-20.8 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 www.Google.com