Investigational new drug studies

AIDSTRIALS (AIDS Clinical Trials). The AIDSTRIALS database [80] provides information about AIDS-related studies of experimental treatments conducted under the FDA s investigational new drug (IND) regulations. AIDSTRIALS contains information about clinical trials of agents undergoing evaluation for use against AIDS, HIV infection, and AIDS-related opportunistic diseases such as Pneumocystis carinii pneumonia (PCP). Detailed information is supplied... 

After completing preclinical testing, a company files an Investigational New Drug (IND) application with the regulators (the FDA in the U.S.), so that clinical studies in man can begin. The IND shows results of all experiments to this point, a detailed proposal for the clinical study, the expected mode of action for the drug, and any side effects observed. All clinical trials will also be reviewed and approved by the Institutional Review Board (IRB) at the clinic where the trials will be run. 

Lumpkin, M. (1996). Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including well-characterized, therapeutic, and biotechnology-derived products, http //www.fda.gov/cder/guidance/phasel.pdf... 

Estimation of Initial Safety and Tolerability. The initial and subsequent administration of an investigational new drug into humans is usually intended to determine the tolerability of the does range expected to be needed for later clinical studies and to determine the nature of adverse reactions that can be expected. These studies typically include both single and multiple dose administration. 

Pharmaceutical firms have to reexamine their strategies to devise means to increase their drug pipelines for continuous streams of products. The high failure rates of Investigational New Drugs during clinical trials (see Exhibit 5.8) necessitate the development of better assay systems and animal models that correlate closely with human pharmacodynamics and pharmacokinetics. The study of pharmacogenomics will be crucial to address this issue. 

The clinical drug development process required by the US FDA, arguably the most stringent in the world, starts with the investigational new drug (IND) application prior to human testing. It reveals information about all known compounds to be used and includes the description of the clinical research plan for the product as well as the protocol for phase I studies. Preclinical study results also need to be revealed. 

Is has long been the policy of the FDA to work as much as possible as a partner of the pharmaceutical industry from the submission of the IND (Investigational New Drug documentation) before the start of clinical studies until the approval of the NDA before marketing of the compound. 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

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