| Generic Drugs Resources |
| Drug Discovery and Development |
| The process of drug discovery and development follows usually the following steps: discovery, development, and marketing support. Enormous costs, over $150 million, are involved in the development of a successful medication. The development process lasts more than 10 years. |
| Drug Discovery New molecules are usually found by synthesis of potentially new medications or chemical modification of existing compounds; screening of natural products or other molecules; rational design; biotechnology. Screening tests using a variety of biologic methods are performed to determine the drug candidate compound. Drug Development This period includes preclinical testing of the candidate compounds, development and analysis of the dosage form, clinical studies, and submission of marketing approval documents. Preclinical testing (Animal pharmacology studies) The preclinical safety testing (done on large number of animals) consists of acute toxicity (single-dose effect), subacute and chronic toxicity (multiple doses effect), embryotoxicity and teratogenicity, carcinogenicity, mutagenicity. Pharmacology Resources Clinical studies The human studies are conducted in accordance with the approved guidelines. The approval for marketing of the new product is regulated in the US by the Food and Drug Administration (FDA). In phase 1 dose-effect studies are performed to a small number of healthy volunteers (25-50) to determine if humans show same responses to the medication. The study is performed by clinical pharmacologists in research centers. In phase 2, the medication is tested in larger group of patients (50-200), to determine its efficacy. These studies are done in special clinical centers. In phase 3, the product is studied in large number of patients to determine its efficacy and safety. Double-blind approach is usually used. This phase is organised in conditions most closely approaching the indications for use. When phase 3 concludes, New Drug Application (NDA) for marketing approval could be submitted to the FDA. The application contains all the reports of the preclinical and clinical studies. The process of approval by the FDA may last more than 3 years. Marketing Support This period includes post-marketing surveillance studies (phase 4 clinical trials), and marketing promotion. New clinical indications are studied, and new formulations developed in order to extend the patent protection. |
| Glossary Brand Name The brand name is the name under which a new pharmaceutical is developed and marketed. This name is patented by the originator company, which has developed the medication. The company receives exclusive rights for marketing of the product with this name. Drug Defined by FDA and US law as any substance intended for use in the diagnosis, cure, relief, treatment or prevention of diseases. Drug Safety All drugs have side effects. Safety is tested in the preclinical and clinical stages. A product is considered more safe when the benefits of its use strongly overweight the risks. Generic Drugs (Generics) Generics are considered identical, or bioequivalent to the brand-name drugs. They contain the same active substance as the original product and have the same quality, efficacy and safety. They are marketed after patent expiry of the brand. Marketing Approval The drugs are evaluated by the authorities and approved before they may be marketed. A licence is issued by the drug agency for approval of the product. Patents New drugs are developed under patent protection. The patent protects the company investments (including research, development, marketing etc), and prohibits other companies from making, using or selling the product. Brand-name drugs are usually given patent protection for more than 20 years. Pharmacokinetic studies Pharmacokinetics studies the processes of absorption, distribution, metabolism, and elimination of the medication in the organism. |
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