Essay

New Pharmaceuticals

Josue Ortiz

Institution

New Pharmaceuticals

Introduction

Drug development process is a lengthy and costly process which can be terminated at any time during the development process. Several reasons can contribute to abandoning the drug; some of them are the presence of dangerous compounds or the irrevelance of the drug to the intended users. The process of delivering the drug into the market takes considerable time, and it can take more than a decade. This paper will discuss the process of delivering a new drug into the market and will give an example of a new drug that has been approved.

New Drug Development Process

New drug development process has three major steps that cost the company over $500 million. The first step starts with preclinical studies. At this stage, new drug is tested on animals with the primary aim of examining its pharmacological and therapeutic compounds as well biologically dangerous compounds. The second step is the Investigational New Drug Application (IND). At this stage, the drug is submitted to the Food and Drug Administration (FDA) for approval before testing it on humans. The company is expected to give details with regard to compound composition, protocols that will be applied in Phase 1 and the clinical research plan. More than 5000 compounds are submitted for clinical testing but only one of them is approved for marketing (Sharp, 2001).

Approval is granted within a period of one month and this marks the onset of clinical testing on human beings and comprises of three phases. At first, the drug is tested on a few healthy individuals (10-30) to ascertain that the drug is safe and can be tested on patients. Phase 1 focuses on safety but not drug’s efficiency (Sharp, 2001).

Phase 2 utilizes a larger population sample of about 100 to 200 and it is conducted on patients with the condition the drug is expected to...