Using Investigational New Drugs

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

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... 

Vaccines There are two IND (investigative new drug) human unlicensed VEE vaccines available. The first, named TC-83, developed in the 1960s is a live, attenuated cell-culture-propagated vaccine produced by the Salk Institute, and is not effective against all the serotypes in the VEE complex. It is used in a single subcutaneous dose of 0.5 mL. 

Three t)rpes of rmusual IND situations deserve special mention. First, the regulations contain a provision governing emergency use of an investigational new drug. Where FDA will permit such use by telephone or other rapid communication means. In these situations, the IND must subsequently be amended to reflect the new situation. Second, FDA will approve specific... 

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. 

---