New Pharmaceuticals essay
Pharmaceutical industry requires significant investments in R&D; moreover, pharmaceutical companies have to comply with strict regulations and procedures before bringing new drugs to the market. The process of developing new drugs is lengthy, complex and costly: it usually takes 10-12 years to bring a new drug to the market and the cost of this process is around $5 billion (Schaster, 2006). The purpose of this paper is to discuss the steps that are required to bring a new pharmaceutical to market and to consider various issues arising in this process.
It is possible to identify three phases of drug development: pre-clinical R&D phase, clinical R&D phase and post-marketing phase (Schaster, 2006). During the pre-clinical phase, the drug is developed and tested in vitro, using computer models and later on animals; the drugs should be tested with regard to toxicity, kinetics and carcinogenicity (Schaster, 2006). At this phase, the future therapeutic usefulness of the drug is estimated, as well as its pharmacological activity and potential harm. After the first phase, the pharmaceutical company files an IND (investigational drug application) to the FDA (Food and Drug Administration) (Schaster, 2006). IND usually includes all data obtained during the first phase, detailed information on the new drug/compound and the plan of clinical research. FDA can disapprove the IND; if during 30 days IND is not rejected, it is approved automatically, and the company can start clinical trials (Schaster, 2006).
During the clinical research phase, human trials take place. This phase can be divided into three stages. At stage I, the drug is first tested on humans; small groups of volunteers are recruited and are placed in small hospital-like units. At this stage, the pharmacodynamics and pharmacokinetics of the drug are studied, as well as adverse reactions and maximal dose that can be tolerated (Schaster, 2006). For this stage, pharmaceutical companies recruit predominantly healthy volunteers (except for some specific drugs like cancer drugs).
If the drug passes the first stage of clinical trial, it enters the second stage. At this stage, the following steps are performed: dose range is determined by trials during several weeks; then the trials for establishing the relationship between the dose and response, and efficacy trials are conducted (Schaster, 2006). At this stage, drug-drug interactions are also explored. The trials at the second stage are conducted on large groups of volunteers, commonly 100-200 people; the volunteers with the necessary condition and/or disease are selected.
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f the drug has successfully passed trials of the second phase, it proceeds to phase 3. At this phase, the drug is tested on large populations and drug efficacy for special populations is considered. Commonly, at least two large clinical trials proving the effectiveness of the drug are required; the trials are randomized, include a control group with placebo and/or an active comparator (Schaster, 2006). In these trials, several thousands of patients can participate. These trials are the most costly: each of them might cost a pharmaceutical company $50-100 million (Schaster, 2006).
Furthermore, the pharmaceutical company should also test the drug on special populations such as lactating women, aged people, people with hepatic or renal insufficiency, etc. Food and drug interactions should also be explored at this phase, as well as effects on concentration (e.g. while driving) and on psychological testing (Schaster, 2006). Drug withdrawal effects, special toxicities and the potential for addiction are explored during phase 3. The results of phase 3 should confirm the findings of phase 2, prove that the drug is efficient for large populations and it is more effective compared to current treatments.
After the drug passes all three phases of trials, the pharmaceutical company files an NDA (new drug application) to the FDA (Schaster, 2006). This is a lengthy document which includes summaries of safety and efficacy, manufacturing and control sections, statistics and results of clinical trials, raw data of trials and other findings of the research (Schaster, 2006). The FDA makes a final decision regarding this drug; it usually takes a year to review the NDA and make conclusion. Furthermore, after the drug is allowed to market, the pharmaceutical company should file safety reports and monitor the effects of the drug.
