DRUGS DEVELOPMENT

Preclinical Trials in Drugs Development

Preclinical Trials in Drugs Development

Introduction

The process of developing new drugs has becoming complex day by day. Development of new drugs has been defined in many contexts but there are different stories behind the drug development in a business and in a science scenario. It has been observed that 90% of the drugs are failed to serve the market after preclinical trials. Many drugs are failed or with drawl just after their launch. Science provides various modern designs by which drugs development can be improved in the future (Rogge & Taft, 2005, p.n.d). The drug processes are very inefficient which leads towards costly and expensive drug discovery. It has been observed that a successful drug can be launched just after 13 years and it is long time period.

Researchers are discovering more technologies and ways in which the future of drug development can make better (Fleming, 2008, pp 1400-1402). This needs a number of new projects which requires scientific knowledge, legal and technical matters and to regulate these projects in an efficient manner. In this article, authors have defined different rules and regulations for drug development and how these rules and regulations can help in drug development for preclinical trials.

(Drug Development Process)

This diagram illustrates the Drug Development process (Brodniewicz & Grynkiewicz, 2010, pp 578-585). The process starts with the discovery of new active molecule then they proceed towards Preclinical studies. Preclinical studies comprises of two tests: “In Vitrio Tests”, these tests involves investigating the safety and efficacy of the drug and “In Vitrio tests in animals”, these includes investigating the safety and efficacy of the particular drug in animals. The next step is called Clinical studies. Clinical studies involve four different phases. Various steps of drug development are described below.

Preclinical Trials

Preclinical Trials involve testing new drugs and medicines, first in laboratories and then on animals before putting them into clinical trials. Preclinical trials are important in finding advantages and disadvantages of the new discovered drugs (Steiner & Witzmann, 2000, pp 2099-2104). Preclinical trials also include comparing the existing treatments, medications and devices with the new one so that those treatments can be updated. For instance, a new treatment for hypertension is replaced with the old treatment in the patients suffering with hypertension. There are some preclinical trials in which patients are selected randomly and the effects of new medications are investigated on them. Clinical Trials mostly takes place at medical universities, schools, offices, clinics and hospitals. Clinical trials have been conducted throughout the world each year for finding effects of upcoming drugs and medicines on human's health (Sims & Miracle, 2002, p 152-153).

The Food and Drug Administration (FDA), each year receives report about new medical devices, medications and other treatment procedures. In the beginning, these clinical trials are only conducted at medical universities but now the trends have been changed and now these clinical trials can take place in almost all settings. The Food and Drug Administration itself examines the new treatments in the preclinical ...