Drug Development

In the early development of potentially useful substances are tested on animals to assess desired effects and toxicity. Substances that appear to be effective and safe, are candidates for human studies. A test plan that describes the clinical trial must be such. For example, by a competent Institutional Review Board (IRB corresponds to the Ethics Committee in Germany) and the FDA (Food and Drug Administration, US Food and Drug Administration) approved, then an IND exemption (Investigational New Drug approval of the drug for use in the study) issued. However, the drug prior to approval for can. B. are not sold by the FDA. At this time the patent term of the substance, which usually gives the patent holder for 20 years the exclusive rights begins.

Promising components can be identified out by a mass screening of hundreds or thousands of molecules for biological activity. Knowing the specific molecular pathophysiology of diseases allows a rational design of drugs by computer modeling or changes to existing pharmaceutical substances. In the early development of potentially useful substances are tested on animals to assess desired effects and toxicity. Substances that appear to be effective and safe, are candidates for human studies. A test plan that describes the clinical trial must be such. For example, by a competent Institutional Review Board (IRB corresponds to the Ethics Committee in Germany) and the FDA (Food and Drug Administration, US Food and Drug Administration) approved, then an IND exemption (Investigational New Drug approval of the drug for use in the study) issued. However, the drug prior to approval for can. B. are not sold by the FDA. At this time the patent term of the substance, which usually gives the patent holder for 20 years the exclusive rights begins. In Phase 1 safety and toxicity are studied in humans: A small number (often 20 to 80) healthy, young, i. d. R. male subjects receive different amounts of the substance to determine the dose at which toxic effects are observed for the first time. In Phase 2 is to determine whether the substance is effective in disease against which it is intended. The substance is administered for up to approximately 100 patients to treat or prevent the announced illness. Another objective is to determine the optimal dose-response range. In phase 3, the effect of the substance in larger, more heterogeneous populations (often hundreds to thousands of subjects) were investigated with the aim to support the efficacy in clinical use of the drug. In this phase, the substance is also compared with existing treatments, a placebo, or both. These trials university clinics, hospitals, practicing physicians and a variety can be involved from research institutions. The goal is to verify the efficacy and more – to reveal effects were not observed in Phase 1 and 2 – positive or negative. When enough data has been collected to justify the admission of the substance and to apply to the FDA for the European Medicines Agency (www.EMEA.EU.int) or the National Administration a New Drug Application may be submitted. The process from early development to drug approval often takes up to 10 years. Following approval and launch of the product (pharmacovigilance post-marketing surveillance,) also studies may in Phase 4 in addition to the ongoing reporting of adverse reactions are carried out. Phase 4 comprises opposed to the stages 1 through 3 mostly larger populations and longer periods of time, thereby infrequent or slowly developing adverse effects are more likely to be recognized as with shorter, smaller-scale studies. The use of this medicine in clinical practice is not subject to the constraints of the narrow inclusion criteria of patients in clinical trials; Drugs, patients are given a higher risk of adverse effects. specific subpopulations (eg. as pregnant women, children, the elderly) are often examined here. Some drugs that have been approved under Phase 3 or other FDA regulatory authorities are taken off the market after Phase 4 serious adverse effects have occurred.

Health Life Media Team

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