Drug development

Drug development


Developing safe and effective drugs is a process that should include an understanding of clinical legal and regulatory matters

New drug development has revolutionized the practice of medicine converting many once fatal or debilitating diseases into almost routine therapeutic exercises For example deaths from cardiovascular disease and stroke have decreased by more than 50 in the USA over the past 30 years This decline is due in part to the discovery and increased use of anti hypertensive cholesterol synthesis inhibitors and drugs that prevent or dissolve blood clots The process of drug discovery and development ahs been greatly affected by investment in new technology and by governmental support of medical research

In most countries the testing of therapeutic agents is now regulated by legislation and closely monitored by governmental agencies This chapter summarizes the process by which new drugs are discovered developed and regulated While the examples used reflects the experience in the USA the pathway of new drug development is generally the same world wide

One of the first steps in the development of a new drug is the discovery or synthesis of a potential new drug molecule and correlating this molecule with an appropriate biologic target Repeated application of this approach leads to this compounds with increased potency and selectivity By law the safety and efficacy of drugs must be defined before they are marketed

In addition to in vitro studies most of the biologic effects of the molecule must be characterized in animals before human drug trial can be started Human testing must then go forward in three conventional phases before the drug can be considered for approval for general use A fourth phase of data gathering and safety monitoring follows after approval for general use

Enormous costs from 150 million to over to over 800 million are involved in the research and development of a single successful new drug Thousands of compounds may be synthesized and hundreds of thousands tested from existing libraries of compounds for each successful new drug that reaches the market It is primarily because of the economic investment and risks involved as well as the need for multiple inter disciplinary technologies that most new drugs are developed in pharmaceutical companies At the same time the incentives to succeed in drug development are equally enormous The world wide market for ethical prescription pharmaceutical in 2001 was 364 billion Moreover it has been estimated that during the second half of 20th century medications produced by the pharmaceutical industry saved more than 15 million lives and 140 billion in the cost of treatment for tuberculosis poliomyelitis coronary artery disease and cerebrovascular disease alone In the USA approximately 10 of the health care dollar is presently spent on prescription drugs

New Chemical Entities NCEs also known as New Molecular Entities NMEs are compounds which emerge from the process of drug discovery These will have promising activity against a particular biological target thought to be important in disease however little will be known about the safety toxicity pharmacokinetics and metabolism of this NCE in humans It is the function of drug development to assess all of these parameters prior to human clinical trials A further major objective of drug development is to make a recommendation of the dose and schedule to be used the first time an NCE is used in a human clinical trial firstinman FIM or First Human Dose FHD

In addition drug development is required to establish the physicochemical properties of the NCE its chemical makeup stability solubility The process by which the chemical is made will be optimized so that from being made at the bench on a milligram scale by a synthetic chemist it can be manufactured on the kilogram and then on the ton scale It will be further examined for its suitability to be made into capsules tablets aeros

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