Developing and testing of new drugs by the pharmaceutical industry

The developing and testing of new drugs is an important responsibility of the pharmaceutical industry. The first tests are “screening” procedures that are intended to Uncover leads indicating possible therapeutic usefulness. After thorough pharmacologic and toxicity testing in experimental animals, a new drug is ready for the initial trial in a human subject. It is practical for a pharmaceutical manufacturer to maintain a clinical research unit and a staff of investigators for performance of the initial human trials. A new therapeutic agent is then placed in the hands of a limited number of experienced and qualified investigators so that adequately controlled studies can be conducted under dose observation. In some instances, as a final evaluation, the drug is subjected to a broad clinical trial by a Zarge number of physicians. If properly conducted, important information can be obtained by the use of a drug tmder conditions found in the practice of medicine. Evidence of hypersensitivity cannot be detected by limited trial. The dinical investigator must plan the study wilh great attention to detail. Every effort must be made to avoid bias. In the development of the drug the tcork of the pharrnaceutical chemist is important in preparing a satisfactory dosage form; the control division must establish criteria for the composition of the ingredients as well as for the final product and must prove the stability. Publication of reports in the scientific journals must include methods and controls for clinical studies and the results. A group of investigators can use one experimental design and pool the findings in a single paper. The investigator should report all data to the manufactllrer as quickly as possible.