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Volumn 44, Issue 3, 1997, Pages 219-225

The contribution of clinical pharmacology surrogates and models to drug development - A critical appraisal

Author keywords

Drug development; Models; Surrogates; Validation

Indexed keywords

CLINICAL PHARMACOLOGY; CLINICAL TRIAL; DECISION MAKING; DRUG COST; DRUG DEVELOPMENT; DRUG DOSE; DRUG INDUSTRY; DRUG SCREENING; HUMAN; MODEL; NONHUMAN; PRIORITY JOURNAL; REVIEW; VALIDATION PROCESS;

EID: 0030884335     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.1997.t01-1-00583.x     Document Type: Review
Times cited : (93)

References (40)
  • 1
    • 0027431320 scopus 로고
    • Relevance of pharmacokinetic studies in volunteers
    • Toon S. Relevance of pharmacokinetic studies in volunteers. Clin Pharmacokinet 1993; 25: 259-262.
    • (1993) Clin Pharmacokinet , vol.25 , pp. 259-262
    • Toon, S.1
  • 2
    • 0029351456 scopus 로고
    • Oral sumatriptan for the acute treatment of migraine: Evaluation of three dosage strengths
    • Cutler N, Mushet GR, Davis R, et al. Oral sumatriptan for the acute treatment of migraine: evaluation of three dosage strengths. Neurol 1995; 45 Suppl 7: S5-9.
    • (1995) Neurol , vol.45 , Issue.7 SUPPL.
    • Cutler, N.1    Mushet, G.R.2    Davis, R.3
  • 3
    • 8544235500 scopus 로고
    • Exploratory development
    • eds Griffin JP, O'Grady J, Wells FO. Belfast: Queens University of Belfast
    • Posner J. Exploratory development. In The Textbook of Pharmaceutical Medicine, Second Edition, eds Griffin JP, O'Grady J, Wells FO. Belfast: Queens University of Belfast, 1994: 291-314.
    • (1994) The Textbook of Pharmaceutical Medicine, Second Edition , pp. 291-314
    • Posner, J.1
  • 4
    • 0027362970 scopus 로고
    • Role of surrogate end points in the evaluation of drugs for heart failure
    • Lipicky RJ, Packer M. Role of surrogate end points in the evaluation of drugs for heart failure. J Am Coll Cardiol 1993; 22 (Suppl A): 179A-184A.
    • (1993) J Am Coll Cardiol , vol.22 , Issue.SUPPL. A
    • Lipicky, R.J.1    Packer, M.2
  • 5
    • 8544256059 scopus 로고
    • General characteristics of clinical surrogates
    • eds Olesen J, Moskowitz M, New York: Lippincott-Raven
    • Rolan PE. General characteristics of clinical surrogates. In Advances in Headache Research Vol 5: Experimental headache models, eds Olesen J, Moskowitz M, New York: Lippincott-Raven, 1995: 27-32.
    • (1995) Advances in Headache Research Vol 5: Experimental Headache Models , vol.5 , pp. 27-32
    • Rolan, P.E.1
  • 6
    • 0024502084 scopus 로고
    • Surrogate endpoints in clinical trials: Cardiovascular diseases
    • Wittes J, Lakatos E, Probstfield J. Surrogate endpoints in clinical trials: cardiovascular diseases. Stat Med 1989; 8: 415-425.
    • (1989) Stat Med , vol.8 , pp. 415-425
    • Wittes, J.1    Lakatos, E.2    Probstfield, J.3
  • 7
    • 0028837732 scopus 로고
    • Calcium antagonists and mortality. Another case of the need for clinical judgement
    • Fagan TC. Calcium antagonists and mortality. Another case of the need for clinical judgement. Arch Int Med 1995; 155: 20.
    • (1995) Arch int Med , vol.155 , pp. 20
    • Fagan, T.C.1
  • 8
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: Definition and operational criteria
    • Prentice R. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989; 8: 431-440.
    • (1989) Stat Med , vol.8 , pp. 431-440
    • Prentice, R.1
  • 9
    • 0026739680 scopus 로고
    • Surrogate endpoints: A basis for a rational approach
    • Boissel J-P, Collet J-P, Moleur P, et al. Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol 1992; 43: 235-244.
    • (1992) Eur J Clin Pharmacol , vol.43 , pp. 235-244
    • Boissel, J.-P.1    Collet, J.-P.2    Moleur, P.3
  • 10
    • 0027396591 scopus 로고
    • Measurement validity in physical therapy research
    • Sim J, Arnell P. Measurement validity in physical therapy research. Phys Ther 1993; 73: 102-115.
    • (1993) Phys Ther , vol.73 , pp. 102-115
    • Sim, J.1    Arnell, P.2
  • 11
    • 0030063324 scopus 로고    scopus 로고
    • Trials reveal no benefit, possible harm of beta carotene and vitamin A for lung cancer
    • Marwick C. Trials reveal no benefit, possible harm of beta carotene and vitamin A for lung cancer. JAMA 1996; 275: 6.
    • (1996) JAMA , vol.275 , pp. 6
    • Marwick, C.1
  • 12
    • 0027938710 scopus 로고
    • Efficacy of the 5-lipoxygenase inhibitor ZD 2138 on allergen-induced early and late responses
    • Nasser SM, Bell GS, Hawksworth RJ, et al. Efficacy of the 5-lipoxygenase inhibitor ZD 2138 on allergen-induced early and late responses. Thorax 1994; 49: 743-748.
    • (1994) Thorax , vol.49 , pp. 743-748
    • Nasser, S.M.1    Bell, G.S.2    Hawksworth, R.J.3
  • 13
    • 0028309047 scopus 로고
    • Appropriate acid suppression for optimal healing of duodenal ulcer and gastrooesophageal reflux disease
    • Howden CW, Burget DW, Hunt RH. Appropriate acid suppression for optimal healing of duodenal ulcer and gastrooesophageal reflux disease. Scan J Gastroenterol - Supplement 1994; 201: 79-82.
    • (1994) Scan J Gastroenterol - Supplement , vol.201 , pp. 79-82
    • Howden, C.W.1    Burget, D.W.2    Hunt, R.H.3
  • 14
    • 0029038425 scopus 로고
    • Decision analysis: Theory and application to medicine
    • Cantor SB. Decision analysis: theory and application to medicine. Prim Care 1995; 22: 261-270.
    • (1995) Prim Care , vol.22 , pp. 261-270
    • Cantor, S.B.1
  • 16
    • 8544253740 scopus 로고
    • Acute tolerance, effects on spirometry and systemic absorption of nebulised 443C81 in healthy volunteers and asthmatic patients
    • July
    • Gray SJ, Rolan PE, Phillips SC, Posner J. Acute tolerance, effects on spirometry and systemic absorption of nebulised 443C81 in healthy volunteers and asthmatic patients. Abstract for British Thoracic Society, July 1990.
    • (1990) Abstract for British Thoracic Society
    • Gray, S.J.1    Rolan, P.E.2    Phillips, S.C.3    Posner, J.4
  • 17
    • 8544277010 scopus 로고
    • Effect of inhalation of a novel enkephalin analogue (443C81) on the response to cold air and metabisulphite challenge in healthy volunteers
    • Gray SJ, Rolan PE, Posner J. Effect of inhalation of a novel enkephalin analogue (443C81) on the response to cold air and metabisulphite challenge in healthy volunteers. Br J Clin Pharmacol 1991; 32: 662-663.
    • (1991) Br J Clin Pharmacol , vol.32 , pp. 662-663
    • Gray, S.J.1    Rolan, P.E.2    Posner, J.3
  • 18
    • 8544272294 scopus 로고
    • Effect of i.v. infusion of a novel enkephalin analogue (443C81) on metabisulphite induced broncoconstriction and intradermal histamine flare in healthy volunteers
    • Phillips SC, Rolan PE, Gray SJ, Posner J. Effect of i.v. infusion of a novel enkephalin analogue (443C81) on metabisulphite induced broncoconstriction and intradermal histamine flare in healthy volunteers. Br J Clin Pharmacol 1991; 32: 663.
    • (1991) Br J Clin Pharmacol , vol.32 , pp. 663
    • Phillips, S.C.1    Rolan, P.E.2    Gray, S.J.3    Posner, J.4
  • 19
    • 7144249774 scopus 로고
    • Compounds designed to bind to haemoglobin
    • ed Beddell CR, John Wiley and Sons Ltd, London
    • Wootton R. Compounds designed to bind to haemoglobin. In The design of drugs to macromolecular targets, ed Beddell CR, John Wiley and Sons Ltd, London, 1992.
    • (1992) The Design of Drugs to Macromolecular Targets
    • Wootton, R.1
  • 21
    • 0027466298 scopus 로고
    • The pharmacokinetics, tolerability and pharmacodynamics of tucaresol (589C80; 4[2-formyl-3-hydroxyphenoxymethyl] benzoic acid), a potential anti-sickling agent, following oral administration to healthy subjects
    • Rolan PE, Parker JE, Gray SJ, et al. The pharmacokinetics, tolerability and pharmacodynamics of tucaresol (589C80; 4[2-formyl-3-hydroxyphenoxymethyl] benzoic acid), a potential anti-sickling agent, following oral administration to healthy subjects. Br J Clin Pharmacol 1993; 35: 419-425.
    • (1993) Br J Clin Pharmacol , vol.35 , pp. 419-425
    • Rolan, P.E.1    Parker, J.E.2    Gray, S.J.3
  • 22
    • 0028917476 scopus 로고
    • Pharmacokinetics and pharmacodynamics of multiple oral doses of tucaresol, an anti-sickling agent, in healthy volunteers
    • Rolan PE, Mercer AJ, Wootton R, Posner J. Pharmacokinetics and pharmacodynamics of multiple oral doses of tucaresol, an anti-sickling agent, in healthy volunteers. Br J Clin Pharmacol 1995; 39: 375-380.
    • (1995) Br J Clin Pharmacol , vol.39 , pp. 375-380
    • Rolan, P.E.1    Mercer, A.J.2    Wootton, R.3    Posner, J.4
  • 23
    • 0029895837 scopus 로고    scopus 로고
    • Tucaresol increases oxygen affinity and reduces haemolysis in subjects with sickle cell anaemia
    • Arya R, Rolan PE, Wootton R, Posner J, Bellingham AJ. Tucaresol increases oxygen affinity and reduces haemolysis in subjects with sickle cell anaemia. Br J Haematol 1996; 93: 817-821.
    • (1996) Br J Haematol , vol.93 , pp. 817-821
    • Arya, R.1    Rolan, P.E.2    Wootton, R.3    Posner, J.4    Bellingham, A.J.5
  • 24
    • 0026080644 scopus 로고
    • Measurement of human cerebral monoamine oxidase type B (MAO-B) activity with positron emission tomography (PET): A dose ranging study with the reversible inhibitor Ro 19-6327
    • Bench CJ, Price GW, Lammertsma AA, et al. Measurement of human cerebral monoamine oxidase type B (MAO-B) activity with positron emission tomography (PET): a dose ranging study with the reversible inhibitor Ro 19-6327. Eur J Clin Pharmacol 1991; 40: 169-173.
    • (1991) Eur J Clin Pharmacol , vol.40 , pp. 169-173
    • Bench, C.J.1    Price, G.W.2    Lammertsma, A.A.3
  • 26
    • 84959744262 scopus 로고
    • The validity of surrogate markers in rheumatic disease
    • Emery P, Luqmani R. The validity of surrogate markers in rheumatic disease. Br J Rheumatol 1993; 32 (Suppl 3): 3-8.
    • (1993) Br J Rheumatol , vol.32 , Issue.3 SUPPL. , pp. 3-8
    • Emery, P.1    Luqmani, R.2
  • 27
    • 0027167578 scopus 로고
    • Surrogate markers for assessing treatment response in HIV disease
    • Rathburn RC. Surrogate markers for assessing treatment response in HIV disease. Ann Pharmacother 1993; 27: 450-455.
    • (1993) Ann Pharmacother , vol.27 , pp. 450-455
    • Rathburn, R.C.1
  • 28
    • 0027409691 scopus 로고
    • Surrogate markers in AIDS clinical trials: Conceptual basis, validation, and uncertainties
    • Lagakos SW. Surrogate markers in AIDS clinical trials: conceptual basis, validation, and uncertainties. Clin Infect Dis 1993; 16 (Suppl 1): S22-25.
    • (1993) Clin Infect Dis , vol.16 , Issue.1 SUPPL.
    • Lagakos, S.W.1
  • 29
    • 8544226722 scopus 로고
    • Complete inhibition of airway and neutrophil response to inhaled platelet activating factor (PAF) by a novel PAF antagonist UK-74,506
    • O'Connor BJ, Ridge SM, Chen-Worsdell YM, Uden S, Barnes PJ, Chung KF. Complete inhibition of airway and neutrophil response to inhaled platelet activating factor (PAF) by a novel PAF antagonist UK-74,506. Am Rev Resp Dis 1991; 143: A156.
    • (1991) Am Rev Resp Dis , vol.143
    • O'Connor, B.J.1    Ridge, S.M.2    Chen-Worsdell, Y.M.3    Uden, S.4    Barnes, P.J.5    Chung, K.F.6
  • 30
    • 0027390946 scopus 로고
    • Effect of the platelet activating factor antagonist UK-74,506 on the early and late response to allergen
    • Kuitert CM, Hui KP, Uthatarkumar S, et al. Effect of the platelet activating factor antagonist UK-74,506 on the early and late response to allergen. Am Rev Resp Dis 1993; 147: 82-88.
    • (1993) Am Rev Resp Dis , vol.147 , pp. 82-88
    • Kuitert, C.M.1    Hui, K.P.2    Uthatarkumar, S.3
  • 31
    • 0029002906 scopus 로고
    • Effect of a novel platelet-activating factor antagonist, modipafant, in clinical asthma
    • Kuitert CM, Angus RM, Barnes NC, et al. Effect of a novel platelet-activating factor antagonist, modipafant, in clinical asthma. Am J Respir Crit Care Med 1995; 151: 1331-1335.
    • (1995) Am J Respir Crit Care Med , vol.151 , pp. 1331-1335
    • Kuitert, C.M.1    Angus, R.M.2    Barnes, N.C.3
  • 32
    • 0024502084 scopus 로고
    • Surrogate endpoints in clinical trials: Cardiovascular diseases
    • Wittes J, Lakatos E, Probstfield J. Surrogate endpoints in clinical trials: cardiovascular diseases. Stat Med 1989; 8: 414-425.
    • (1989) Stat Med , vol.8 , pp. 414-425
    • Wittes, J.1    Lakatos, E.2    Probstfield, J.3
  • 33
    • 0026510769 scopus 로고
    • An evaluation of the antihistamine activity of acrivastine and its onset in human skin
    • Manna VK, Marks P, Gibson JR. An evaluation of the antihistamine activity of acrivastine and its onset in human skin. J Int Med Res 1992; 20: 106-111.
    • (1992) J int Med Res , vol.20 , pp. 106-111
    • Manna, V.K.1    Marks, P.2    Gibson, J.R.3
  • 34
    • 0027305103 scopus 로고
    • Ipecacuanha-induced emesis: A human model for testing antiemetic drug activity
    • Minton N, Swift R, Lawlor C, et al. Ipecacuanha-induced emesis: a human model for testing antiemetic drug activity. Clin Pharmacol Ther 1993; 54: 53-57.
    • (1993) Clin Pharmacol Ther , vol.54 , pp. 53-57
    • Minton, N.1    Swift, R.2    Lawlor, C.3
  • 35
    • 0027340252 scopus 로고
    • Inhibition of leukotriene D4-induced bronchocontriction in subjects with asthma: A concentration-effect study
    • Smith LJ, Glass M, Minkwitz MC. Inhibition of leukotriene D4-induced bronchocontriction in subjects with asthma: a concentration-effect study. Clin Pharmacol Ther 1993; 54: 430-436.
    • (1993) Clin Pharmacol Ther , vol.54 , pp. 430-436
    • Smith, L.J.1    Glass, M.2    Minkwitz, M.C.3
  • 36
    • 0002294195 scopus 로고
    • A microcomputerised system for evaluating the cognitive actions of drugs in the young, elderly and demented
    • Wesnes K, Simpson PM, Christmas L. A microcomputerised system for evaluating the cognitive actions of drugs in the young, elderly and demented. Eur J Clin Pharmacol 1989; 36: A38.
    • (1989) Eur J Clin Pharmacol , vol.36
    • Wesnes, K.1    Simpson, P.M.2    Christmas, L.3
  • 38
    • 0028210996 scopus 로고
    • Laboratory methods for the conduct of experimental malaria challenge of volunteers
    • Davis JR. Laboratory methods for the conduct of experimental malaria challenge of volunteers. Vaccine 1994; 12: 321-327.
    • (1994) Vaccine , vol.12 , pp. 321-327
    • Davis, J.R.1
  • 39
    • 0021934436 scopus 로고
    • Effects of an opiate on cold-induced pain and the CNS in healthy volunteers
    • Posner J, Telekes A, Crowley D, et al. Effects of an opiate on cold-induced pain and the CNS in healthy volunteers. Pain 1985; 23: 73-82.
    • (1985) Pain , vol.23 , pp. 73-82
    • Posner, J.1    Telekes, A.2    Crowley, D.3
  • 40
    • 0024321898 scopus 로고
    • Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • The CAST investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321: 406-412.
    • (1989) N Engl J Med , vol.321 , pp. 406-412


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