SUCCESSFUL NDA's

Dr. Lasseter has been Principal Investigator of approximately 1200 clinical studies (over past 38 years) of the safety and efficacy and mechanisms of action of Phase I, II and III drugs as well as bioavailability and pharmacokinetic studies in normal subjects and in special populations. Numerous clinical studies have been successfully audited by sponsoring institution audit teams and by Food and Drug Administration Audit Teams. Virtually all studies have been conducted under auspices of active IND applications and approximately 60 successful NDA's have contained data generated by these studies. These include:

acrovastine, alendronate, amiloride, amrinone, arbutamine, atenolol, benzazepril, candesartan cilexetil, carteolol, caspofungin, ciprofloxacin, dofetilide, enalapril, encainide, eplerenone, recombinant erythropoietin, etodolac, famotidine, felodipine, finasteride, flecanide, fosinopril, galantamine, grepafloxacin, indapamide, irbesartan, leucovorin, lisinopril, losartan, meropenem, milrinone, moexepril, montelukast, nefazodone, nimodipine, nisoldipine, nitroprusside, nizatidine, oxaprozin, penbutalol, pinacidil, piperacillin, piroxicam, prazosin, ramipril, 13-cis retinoic acid, rofecoxib, sinemet CR, sirolimus, sitagliptin, sulindac, tegaserod, timolol, terazocin, tocanide, trandolapril, valsartan, venlafaxin, zafirlukast, zolmitriptan and zolpidem.