Investigational Use Of
Drugs
Prepared By: Jay Thakkar (2154591823011)
Mayur Patil (2154591823052)
Suraj Patil(2154591823025)
Kunal Patil(2154591823057)
Under The Guidance Of:
Prof. Bharat Mali Sir
Introduction:
Definition:
Investigational drugs are those drugs which are under
consideration but not yet approved by the Food & Drug
Administration(FDA) or legal authority of the respective country
for the human use.
Description Of Investigational Drug
Use:
• Safe
• Effective
• Need
• Potential benefits
• Side effects
• Treatment options
• Etc.
Principle Involved In Investigational
Drugs:
1. Safety & Efficacy
2. Ethical considerations
3. Informed consent
4. Patient benefits
5. Adequate scientific evidence
Classification of Investigational Drugs:
• 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 USP,NF or passed by the FDA for
commercial Concern.
• ④ Class D:- Drugs are preparations which have been accepted
for use in the hospital and are listed in the hospital formulary.
• Another classification which can be adapted to any hospital
pharmacy operations:
• General
• Conditional
• Investigational
Control, Identification of
Investigational Drugs:
All investigational drugs should be registered with the pharmacy & therapeutic committee this may
accomplished by a letter from the principle investigator which provides the following information:
1. New drug name
2. Generic name
3. Manufacturer
4. Chemical name
5. General chemistry
6. Pharmacology
7. Toxicology
8. Dosage range
9. Route of administration
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Role Of Hospital Pharmacist in
Investigational Drugs:
1. Learning,education & mentoring
2. Drug therapy management
3. Problem solving & conflict resolution
4. Inter personal & communication
5. Operational & distributive skills
6. Leadership & strategic planning
7. Research & development
8. Ethical behaviour & professionalism
9. Patients,advocacy,empathy & safety
Role Of Advisory Committee in
Investigational Drugs:
• The Generic Drugs Advisory Committee is to advice on the safety
and effectiveness 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.
• The FDA regulates more than 1,50,000 marketed drugs and
medical devices.
• At any time, nearly 3,000 investigational new drugs are being
developed