Subjective symptoms and quality of life in healthy subjects during a phase I study

European Journal of Clinical Pharmacology

Volumn 51, Issue 3-4, 1996, Pages 215-219

  Schuppel R ^a   Boos, B ^a   Buhler G ^a   Lataster, M ^b   Peters, T ^a  

^a UNIVERSITY HOSPITAL ULM   (Germany)

^b Knoll AG   (Germany)

Author keywords

digitalis; quality of life; health status; phase I study

Indexed keywords

DIGITALIS; DIGOXIN;

ADULT; ARTICLE; CLINICAL TRIAL; HUMAN; MALE; NORMAL HUMAN; POPULATION; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; VOLUNTEER;

ADOLESCENT; ADULT; DIGOXIN; HEALTH STATUS; HUMANS; MALE; QUALITY OF LIFE;

EID: 0030472459     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002280050186     Document Type: Article

References (16)

1. Commission of the European Community (1989) Regulation of drugs in the European Community, vol 3. Pharmacokinetic research in man (german version). EGKS-EWG-EAG, Brüssel, pp 153-159
2. Sarason J, Johnson J, Siegal J (1978) Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol 46: 932-946
3. Fahrenberg J (1975) Die Freiburger Beschwerdeliste FBL. Zschr Klin Psychol 4: 79-100
4. Abele-Brehm A, Brehm W (1986) Zur Konzeptualisierung und Messung von Befindlichkeit. Die Entwicklung der "Befindlichkeitsskalen". Diagnostica 32: 209-228
5. Fahrenberg J, Myrtek M, Wilk D, Kreutel K (1986) Multimodale Erfassung der Lebenszufriedenheit: Eine Untersuchung an Herz-Kreislauf-Patienten. Psychother Med Psychol 36: 347-354
6. Banks MH, Beresford SA, Morrell DC, Waller JJ, Watkins CJ (1975) Factors influencing demand for primary medical care in women aged 20-44 years: a preliminary report. Int J Epidemiol 4: 189-195
7. Hannay DR (1979) The symptom iceberg: a study in community health. Routledge & Paul, London
8. Haisch J (1995) The perception of illness symptoms by patients and their doctors. Munch Med Wschr 137: 31-36
9. Reidenberg MM, Lowenthal DT (1968) Adverse nondrug reactions. N Engl J Med 279: 678-679
10. Sibille M (1990) Selection of healthy volunteers for phase I studies. Fundam Clin Pharmacol 4 [Suppl.] 2: 167s-176s
11. Rosenzweig P, Brohier S, Zipfel A (1993) The placebo effect in healthy volunteers: Influence of experimental conditions on the adverse events profile during phase I studies. Clin Pharm Ther 54: 578-583
12. Sibille M, Deigart N, Olagnier V, Durand DV, Levrat R (1992) Adverse events in phase one studies: a study in 430 healthy volunteers. Eur J Clin Pharmacol 42: 389-393
13. Davenäs E, Dahlöf C, Olofsson B, Wiklund I (1990) An instrument for quantifying subjective symptoms among untreated and treated hypertensives: Development and documentation. J Clin Res Pharmacoepidemiol 4: 205-217
14. Drossman DA, McKee DC, Sandier RS, Mitchell CM, Lowman BC, Burger MA, Cramer EC (1988) Psychosocial factors in the irritable bowel syndrome: a multivariate study of patients and nonpatients with IBS. Gastroenterology 95: 701-708
15. Kleinman A, Eisenberg J, Good B (1978) Culture, illness and care: clinical lessons from anthropologic and cross-cultural research. Ann Int Med 88: 251-258
16. Spilker B (1990) Quality assessment in clinical trials. Raven, New York