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Investigational new drug, IND

Investigational new drug (IND), 165 lodination (aromatic), 551 Iodoform reaction. 854-855 lodomethane, bond length of, 335 bond strength of, 335 dipole moment of. 335... [Pg.1302]

Akron Research Commercialization Corp. has recently disclosed a drug candidate based on Ag-NHC complexes (Silvamist ). These NHC complexes were proven efficient for the treatment of respiratory diseases, and the company is currently applying for Investigational New Drug (IND) status with the FDA (US Food and Drug Administration)... [Pg.323]

CFR - Part 312.33 discusses what is required for an Investigational New Drug (IND) application. Part 312.33 discusses the requirements for the annual reporting for the IND. This reporting requires you to create adverse event, death, and subject dropout summaries annually for any drug under an IND application. [Pg.7]

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... [Pg.776]

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. [Pg.91]

Vaccines Yes. LVS - Live Attenuated Vaccine as an investigational new drug (IND) administered once by scarification. A two week course of tetracycline is effective as prophylaxis when given after exposure. [Pg.182]

Only one in 10 Investigational New Drugs (INDs) will become approved as drugs. Half the IND failures are due to unacceptable efficacy. One-third fail because of safety issues. [Pg.159]

An Investigational New Drug (IND) application to the FDA seeks permission for a human chnical trial to be conducted. An IND apphcation is detailed under 21 CFR Part 312. The process for an IND is summarized in Fig. 8.2. [Pg.234]

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See also in sourсe #XX -- [ Pg.263 ]



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Drugs, new

IND

IND, Investigation New Drug

IND, Investigation New Drug

IND, Investigation New Drug application

Investigational New Drug IND), applications for

Investigational new drug application (IND

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