[1] US FDA, Off Pharmaceut Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
[2] Univ Michigan, Coll Pharm, Ann Arbor, MI 48109 USA
[3] Univ Calif San Francisco, Sch Pharm & Med, Dept Bioengn & Therapeut Sci, San Francisco, CA 94143 USA
[4] Uppsala Univ, Dept Pharm, Uppsala, Sweden
[5] US FDA, Ctr Drug Evaluat & Res, Off Gener Drugs, Off Pharmaceut Sci, Rockville, MD 20857 USA