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Investigational new drug

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]

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. [Pg.89]

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. [Pg.92]

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. [Pg.118]

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]

Intellectual Property In general, the investigator retains ownership and development rights to their invention, consistent with Bayh-Dole provisions [4]. The investigator is expected to submit an Investigational New Drug Application (INDA) with the FDA under their own sponsorship. Specific information can be found at the NIH-RAID website. [Pg.365]

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