Defining the Maximum Tolerated Dose: Investigator, Academic, Industry and Regulatory Perspectives
1997; Wiley; Volume: 37; Issue: 9 Linguagem: Inglês
10.1002/j.1552-4604.1997.tb05624.x
ISSN1552-4604
AutoresNeal R. Cutler, John J. Sramek, David J. Greenblatt, Philip Chaikin, Neville F. Ford, Lawrence J. Lesko, Brian Davis, Roger Williams,
Tópico(s)Health Systems, Economic Evaluations, Quality of Life
ResumoThe Journal of Clinical PharmacologyVolume 37, Issue 9 p. 767-783 Defining the Maximum Tolerated Dose: Investigator, Academic, Industry and Regulatory Perspectives Dr. Neal R. Cutler MD, Corresponding Author Dr. Neal R. Cutler MD California Clinical Trials, Beverly Hills, California.8500 Wilshire Blvd., 7th Floor, Beverly Hills, CA 90211.Search for more papers by this authorDr. John J. Sramek PharmD, Dr. John J. Sramek PharmD California Clinical Trials, Beverly Hills, California.Search for more papers by this authorDr. David J. Greenblatt MD, FCP, Dr. David J. Greenblatt MD, FCP Tufts University School of Medicine, Boston, Massachusetts.Search for more papers by this authorDr. Philip Chaikin MD, PharmD, Dr. Philip Chaikin MD, PharmD Worldwide Clinical Development, Rhone-Poulenc Rorer, Pennsylvania.Search for more papers by this authorDr. Neville Ford MD, PhD, FCP, Dr. Neville Ford MD, PhD, FCP Department of Clinical Pharmacology, Bristol-Myers Squibb Company, Princeton, New Jersey.Search for more papers by this authorDr. Lawrence J. Lesko PhD, Dr. Lawrence J. Lesko PhD US Food and Drug Administration, Rockville, Maryland.Search for more papers by this authorDr. Brian Davis MD, Dr. Brian Davis MD Clinical Trials Unit, UK Medicines Control Agency, London, England.Search for more papers by this authorDr. Roger L. Williams MD, Dr. Roger L. Williams MD US Food and Drug Administration, Rockville, Maryland.Search for more papers by this author Dr. Neal R. Cutler MD, Corresponding Author Dr. Neal R. Cutler MD California Clinical Trials, Beverly Hills, California.8500 Wilshire Blvd., 7th Floor, Beverly Hills, CA 90211.Search for more papers by this authorDr. John J. Sramek PharmD, Dr. John J. Sramek PharmD California Clinical Trials, Beverly Hills, California.Search for more papers by this authorDr. David J. Greenblatt MD, FCP, Dr. David J. Greenblatt MD, FCP Tufts University School of Medicine, Boston, Massachusetts.Search for more papers by this authorDr. Philip Chaikin MD, PharmD, Dr. Philip Chaikin MD, PharmD Worldwide Clinical Development, Rhone-Poulenc Rorer, Pennsylvania.Search for more papers by this authorDr. Neville Ford MD, PhD, FCP, Dr. Neville Ford MD, PhD, FCP Department of Clinical Pharmacology, Bristol-Myers Squibb Company, Princeton, New Jersey.Search for more papers by this authorDr. Lawrence J. Lesko PhD, Dr. Lawrence J. Lesko PhD US Food and Drug Administration, Rockville, Maryland.Search for more papers by this authorDr. Brian Davis MD, Dr. Brian Davis MD Clinical Trials Unit, UK Medicines Control Agency, London, England.Search for more papers by this authorDr. Roger L. Williams MD, Dr. Roger L. Williams MD US Food and Drug Administration, Rockville, Maryland.Search for more papers by this author First published: 11 March 2013 https://doi.org/10.1002/j.1552-4604.1997.tb05624.xCitations: 26AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL REFERENCES 1 Cutler NR, Sramek JJ, Veroff AE: Alzheimer's Disease: Optimizing Drug Development Strategies. Chichester: John Wiley & Sons, 1994. 2 Cutler NR, Sramek JJ, Kurtz NM: Anxiolytic Compounds: Perspectives in Drug Development. Chichester: John Wiley & Sons, 1996. 3 Cutler NR, Sramek JJ: Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study. Eur J Clin Pharmacol 1995b; 48: 421– 428. 4 Koch HJ: Concept of bridging studies and ethical concerns. Eur J Pharmacol 1996; 50: 245– 246. 5 Carter SK: Clinical trials in cancer chemotherapy. Cancer 1997; 40: 544– 557. 6 Geller NL: Design of phase I and II clinical trials in cancer: a statistician's view. Cancer Invest 1984; 2: 483– 491. 7 Storer BE: Design and analysis of phase I clinical trials. Biometrics 1989; 45: 925– 937. REFERENCES 8 Cutler NR, Sramek JJ: Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study. Eur J Clin Pharmacol 1995; 48: 421– 428. REFERENCES 9 Cutler NR, Murphy MF, Nash RJ, Prior PL, DeLuna DM: Clinical safety, tolerance, and plasma levels of the oral anticholinesterase 1,2,3,4-tetrahydro-9-aminoacridin-1-oL-maleate (HP 029) in Alzheimer's disease: preliminary findings. J Clin Pharmacol 1990; 30: 556– 561. 10 Sramek JJ, Block GA, Reines SA, Sawin SF, Barchowsky A, Cutler NR: A multiple-dose safety trial of eptastigmine in Alzheimer's disease, with pharmacodynamic observations of red blood cell cholinesterase. Life Sci 1994; 56: 319– 326. 11 Sramek JJ, Hurley DJ, Wardle TS, Satterwhite JH, Hourani J, Dies F, Cutler NR: The safety and tolerance of xanomeline tartrate in patients with Alzheimer's disease. J Clin Pharmacol 1995; 35: 800– 806. 12 Sramek JJ, Sedman AJ, Reece PA, Hourani J, Bockbrader H, Cutler NR: Safety and tolerability of CI-979 in patients with Alzheimer's disease. Life Sci 1995; 57: 503– 510. 13 Sramek JJ, Vierek C, Huff FJ, Wardle TS, Hourani J, Stewart JA, Cutler NR: A "bridging" (safety/tolerance) study of bespiridine hydrochloride in patients with Alzheimer's disease. Life Sci 1995; 57: 1241– 1248. 14 Sramek JJ, Anand R, Wardle TS, Irwin P, Hartman RD, Cutler NR: Safety/tolerability trial of SDZ ENA 713 in patients with probable Alzheimer's disease. Life Sci 1996; 58: 1201– 1207. 15 Cutler NR, Sramek JJ, Seifert RD, Sawin SF: The target population in phase I clinical trials of acetylcholinesterase inhibitors in dementia: the role of the "bridging study." In, B Corain, M Iqbal, M Nicolini, B Winblad, H Wisniewski, P Aztta (eds.): Alzheimer's Disease: Advances in Clinical and Basic Research. Sussex, UK: John Wiley & Sons, 1993; 558– 562. 16 Cutler NR, Sramek JJ: The target population in phase I clinical trials of cholinergic compounds in Alzheimer's disease: the role of the "bridging study." Alzheimer Dis Assoc Disord 1995; 9: 139– 145. 17 Cutler NR, Sramek JJ: Scientific and ethical concerns in clinical trials in Alzheimer's patients: the bridging study. Eur J Clin Pharmacol 1995; 48: 421– 428. 18 Cutler NR, Sramek JJ: Drug development must be optimized in order to choose the correct strategy. In, K Iqbal, JA Mortimer, B Winblad, HM Wisniewski (eds.): Research Advances in Alzheimer's Disease and Related Disorders. Sussex, UK: John Wiley & Sons, 1995; 263– 271. 19 Cutler NR, Sramek JJ: The bridging study: optimizing the dose for phase II/III. In, R Becker, E Giacobini (eds.): Alzheimer Disease: From Molecular Biology to Therapy. Boston: Birkhaüser, 1996; 387– 391. REFERENCES 20 Colburn WA: Controversy V: phase I, first time in man studies. J Clin Pharmacol 1990; 30: 210– 222. 21 Posvar EL, Sedman AJ: New drugs: first time in man. J Clin Pharmacol 1989; 29: 961– 966. 22 Storer BE: Design and analysis of phase I clinical trials. Biometrics 1989; 45: 925– 937. 23 Ward JF, Nardi RV: Using early drug development data to design phase III trials. Drug Inform J 1991; 25: 335– 344. 24 Beer B, Ieni JR, Wu W, Clody D, Amorusi P, Rose J, et al: A placebo-controlled evaluation of single, escalating doses of CL 284,846, a non-benzodiazepine hypnotic. J Clin Pharmacol 1994; 34: 335– 344. 25 Smith RB, Kroboth PD, Varner PD: Pharmacodynamics of triazolam after intravenous administration. J Clin Pharmacol 1987; 27: 971– 979. REFERENCES 26 Ratain MJ, Mick R, Berezin F, Janisch L, Schilsky RL, Williams SF, Smiddy J: Clinical trials and therapeutics: paradoxical relationship between acetylator phenotype and amonafide toxicity. Clin Pharmacol Ther 1991; 50(5, pt 1): 573– 579. 27 Storer BE: Small-sample confidence sets for the MTD in a phase I clinical trial. Biometrics 1993; 49: 1117– 1125. 28 Collins JM, Grieshaber CK, Chabner BA: Pharmacologically guided phase I clinical trials based upon preclinical drug development. J Natl Cancer Inst 1990; 82: 1321– 1326. 29 Voisin EM, Ruthsatz M, Collins JM, Hoyle PC: Extrapolation of animal toxicity to humans. Regul Toxicol Pharmacol 1990; 12: 107– 116. 30 Porikos KP, Van Itallie TB: Diet-induced changes in serum transaminase and triglyceride levels in healthy adult men. Am J Med 1983; 75: 624– 630. REFERENCES 31 Sheiner LB: A new approach to clinical drug development. In, Gender Studies in Product Development: Scientific Issues and Approaches. Rockville, MD: FDA Workshop, November 67, 1996. 32 Collins JM, Grieshaber CK, Chabner BA: Pharmacologically guided phase I clinical trials based on preclinical drug development. J Natl Cancer Inst 1990; 82: 1321– 1326. 33 Sramek JJ, Viereck C, Huff FJ, Wardle T, Hourani J, Stewart JA, Cutler NR: A "bridging" (safety tolerance) study of besipirdine hydrochloride in patients with Alzheimer's disease. Life Sci 1995; 57: 1241– 1248. 34 Cutler NR, Sramek JJ: Scientific and ethical concerns in clinical trials in Alzheimer's patients. Eur J Clin Pharmacol 1995; 48: 421– 428. 35 Cutler NR, Sramek JJ: The target population in phase I clinical trials of cholinergic compounds in Alzheimer's disease: the role of the "bridging study." Alzheimer Dis Rel Disord 1995; 9: 139– 145. 36 Cutler NR, Sramek JJ, Murphy MF, Nash RJ: Alzheimer's patients should be included in phase I clinical trials to evaluate compounds for Alzheimer's disease. J Geriatr Psychiatry Neurol 1992; 5: 192– 194. Citing Literature Volume37, Issue9September 1997Pages 767-783 ReferencesRelatedInformation
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