Ethics at Phase 0: Clarifying the Issues

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See Korieth , supra note 5.

See Saleem , supra note 6; Lappin G. , “Use of Microdosing to Predict Pharmacokinetics at the Therapeutic Dose: Experience with 5 Drugs,” Clinical Pharmacology and Therapeutics 80, no. 3 (2006): 203–15.

A search on the Web site <Clinicaltrials.gov> turned up zero hits for various spellings of microdos* or micro-dos*; and only one protocol containing “phase 0” in its title, available at <http://clinicaltrials.gov> (last visited August 2, 2007).

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See Korieth , supra note 5.

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See Korieth , supra note 5.

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See Wadman , supra note 13.

See Food and Drug Administration, supra note 1.

See Food and Drug Administration, supra note 3.

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See Twombly , supra note 10.

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See Lappin , supra note 8.

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See Twombly , supra note 10.

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General Principles of the IND Submission, 21 CFR 312.22

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See Branca , supra note 24.

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