tutorialpoint.org

B.Pharm Lab. Instruction Manuals

Pharmacology I

APHE Anatomy, Physiology, and Health Education

Pharmaceutical Analysis

Pharmacy study material

General Pharmacology

Bones and Skeleton System

Bone disease (Gout) (Rheumatoid arthritis) (Osteoarthritis) (Osteoporosis)

Cancer and music therapy

Memory of water

Steps of drug development (cont'd...)

Four phases of clinical development (cont'd...)

d. Phase IV of clinical trial

The phase III trial lacks sufficient study to confirm about the safety of the drug. The adverse drug reaction to individual patients (idiosyncrasy) or among particular species, individual drug responses, withdrawal effect, long term adverse drug reaction, drug interactions, contraindications in any disease etc. are not possible to be determined in trial III.

Influence of genetic variation on drug responses is called the pharmacogenetics and the science, deals with the use of pharmacogenetic information to guide the therapeutic use of drugs is called pharmacogenomics. The study of the drug on population is called pharmacoepidemiology. This is the reason the drug is monitored for years after marketing. Another important interest of the manufacturer is to find out the profit for marketing of the drug, as existing drugs are available in the market for same disease. The branch of pharmacy, deals with the health economic aim of to qualtify the cost and benefits of a new drug in economic basis is called pharmacoeconomics. The post marketing monitoring of the drug is called the pharmacovigilance study. The manufacturer gathers the information for more than 1000 of patients in this period. The decision to withdraw or re manufacturing of the drug depends upon this trial [Rang MP et. al., 2007].

Figure. 3. Timeline to market a new drug [Rang MP et. al., 2007]

Figure. 4. Representation of the number of lead in different stages of drug development [Rang MP et. al., 2007]

Reference

[Rang MP et. al., 2007] Rang HP, Dale MM, Ritter J M, Moore P K, Pharmacology, 5th Edition, Elsevier, 2-752, 2007.

< Prev.Page   1   2   3   4   5   6   7   8   9   10   11   12   13   14   15   16   Next page>