PHARMACOLOGY:
The study of pharmacokinetics and pharmacodynamics i.e. How the body treats the drug (movement in the body) and how the drug affects the body respectively.
SIGNIFICANCE OF PHARMACOLOGICAL EXPERIMENTATION:
- The main and most important purpose of a pharmacological experiment is to discover and develop new drugs. The first step in the development of a new drug is the discovery process which involves the conversion of a chemical substance into a drug entity. A drug may be defined as a substance that brings about a change in biological function through its chemical or other actions. There's a continuous search for safer and better new drugs for better management of the disease. Every year new drugs are introduced into the market, and enormous costs mounting up to billions of dollars are involved in the development of a single successful new drug. During research and development pharmacological experiments, animal testing, and clinical trials are conducted to determine the efficacy and safety of drugs.
- In the drug development process, regulatory agencies are involved to ensure the objectives concerned chiefly with the safety and efficacy of the molecules. The Food and Drug Administration is the administrative body that regulates the development process in the USA and official regulations to ensure the development of effective and safe medicine whether by selection amongst those drugs used in traditional systems or by modern invention. Unsafe or ineffective medicines are identified and eliminated. Official drug regulatory agencies are responsible for looking after the processes for marketing approval of new drug development processes and products. The comprehensive drug regulatory law was passed in the USA in 1938 following the deaths of about 107 people due to the use of diethylene glycol as a solvent for the liquid formulation of sulphanilamide. No prior test on animals was done for its toxicity and the mixture was prepared and marketed.
- The thalidomide story is another important example that altered the drug testing requirement and stimulated drug regulating legislation. An estimated 10,000 children were born with birth defect (PHOCOMELIA) in Europe because of maternal exposure to an agent named thalidomide. This tragedy lead to the requirement for more extensive studies on the testing of new drugs and played an important role in identifying most of the hazards likely to be associated with the use of new drugs and playing some statistical limit to the frequency of occurrence of such events.
- Another purpose of the pharmacological experiments is that intellectuals find it satisfying to know about the nature. In the process of drug research people also make money and find it an exciting tool to know about the human body and its basic life process.
- Some of the pharmacological experiments are included in the official compendia. There are pharmacopoeial requirements i.e. an official test of drug and bioassays are given. Biological testing includes the quantitative assay of drugs by a biological method as well as the application of quantitative biological tests; such testing uses intact animals and animal preparations i.e. living tissues and cells or microorganisms.
- Most drugs are assayed chemically and chemical assay quantitatively determines the amount of a specific compound or the structural moiety present in a given sample. On the basis of concentration, an assumption is made relative to the biological activity of the sample. For example, Digitalis extracts are bio-assayed to determine total glycoside and pharmacological activity. The response due to a drug is measured and then the amount of the drug required to produce the desired effect is given in milligrams or international units. Other examples are insulin, glycogen, heparin, vitamins, etc.
- Another purpose of pharmacological experiments is to teach students. By observing and performing the experiments students believe in what they study.
- Another purpose of doing pharmacological experiments is to get higher educational degrees by research i.e. M.S., Ph.D., etc. ultimately improving job satisfaction.
- In short, pharmacological experiments are conducted to discover and develop new drugs or to reduce toxicity and improve the efficacy of already available drugs. All these are the efforts to lessen the human sufferings and to serve for the betterment of mankind.
- Most of the pharmacological experiments are conducted in research laboratories of pharmaceutical industries, (These are known as research and development departments) in universities, institutes (government institutes such as the National Institute for Health (NIH) in hospitals, clinical settings involving communities are known as preclinical and clinical studies on animal and human subjects respectively.
- Various scientists conduct these experiments such as pharmacists, chemists, microbiologists, biochemists, pharmacologists, physiologists, toxicologists, molecular biologists, statisticians for the tabulation of analysis, computer scientists for computer drug designing, and physicians in clinical trials. In short, it is a multidisciplinary task.
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