Principles and Practice of Pharmaceutical Medicine

(Elle) #1

Dinsdale JE, Rollnik JD, Shapiro H. 1995.
‘The effect of ethnicity on prescriptions for
patient-controlled analgesia for postoperative pain’.
Pain 66 (1): 9–12.
Doi T. 1973. ‘The anatomy of dependence’.Tokyo
Kadansha International.
Drayer DE, Reidenberg MM. 1977. ‘Clinical conse-
quences of polymorphic acetylation’.Clin. Pharma-
col. Ther. 22 : 251–258.
Dziewanowska ZE. 1992. ‘International harmonization
of clinical trials’. InFifth World Conference on
Clinical Pharmacology and Therapeutics, Yoka-
hara, Japan, July.
Eap CB, Bauman P. 1989. The generic polymorphism of
humana-1-acid glycoprotein: genetics, biochemis-
try, physiological functions and pharmacology.
Prog. Clin. Biol. Res. 300 : 111–125.
Edwards LD. 1991. ‘Most major companies test med-
icines in women, monitor data for gender differ-
ences’. In In Development: New Medicines for
Women(1991 Survey). Pharmaceutical Manufac-
turers’ Association: Washington; 27–28.
Edwards LD. 1992.Gender and Ethnic Monitoring
Survey. Reported PERI Workshop. Pharmaceutical
Manufacturers’ Association.
Eichelbaum M, Gross AS. 1990. ‘The genetic poly-
morphism of debrisoquine/sparteine clinical aspects’.
Pharmacol. Ther. 46 : 377–394.
Eisenberg L. 1973. ‘The future of psychiatry’.Lancet 2 :
1371–1373.
Federal Register. 1998. ‘Ethnic factors in the accept-
ability of foreign clinical data (E5)’.Federal Reg-
ister 63 (111): 31790–31796.
Fairburn WD. 1989. ‘Japan drug regulations – a United
States industrial perspective’. Regulat. Affairs 1 :
25–33.
Folsom AR, Rosamond WD, Shahar E, Cooper LS,
et al. 1999. ‘Prospectual study of markers of
hemostatic function with risk of ischemic stroke.
The Athero Sclerosis Risk in communities (ARIC)
study investigators’.Circulation 100 (7): 736–742.
Food and Drug Administration. 1975. ‘New drugs for
investigational use: adoption of informational clin-
ical research standards: acceptance of foreign data’.
Federal Register 40 (69): 16052–16057.
Food and Drug Administration. 1985. ‘New drug and
metabolic regulations; final rule’.Federal Register
50 (36): 7452, 7483–7485, 7505.
Freis ED. 1986. ‘Antihypertensive agents’. InEthnic
Differences in Reactions to Drugs and Xenobiotics,
Kalow W, Goedde HW, Agarwal DP (eds). Alan R.
Liss: New York; 313–322.


Gibaldi M. 1992a. ‘Pharmacogenetics: Part I’.Ann.
Pharmacother. 26 : 121–126.
Gibaldi M. 1992b. ‘Pharmacogenetics: Part II’.Ann.
Pharmacother. 26 : 255–261.
Gould SE, Hayashi T, Nakashima T, Shohoji T,et al.,


  1. ‘Coronary heart disease and stroke. Athero-
    sclerosis in Japanese men in Hiroshima, Japan and
    Honolulu, Hawaii’.Arch. Pathol. 93 (2): 98–102.
    Hall DH. 1990. ‘Pathophysiology of hypertension in
    Blacks’.Am. J. Hypertens. 3 : 366S–371S.
    Hartog J, Hartog EA. 1983. ‘Cultural aspects of health
    and illness behavior in hospitals’.West J. Med.
    139 (6): 910–926.
    Harvey C, Walker S. 1993. ‘Review of European CMR
    database for 21 drugs common to the ‘West’ and
    Japan’. In E5 Workshop Report ICH-2, Orlando.
    Henry CJ, Emery B, Piggot S. 1987. ‘Basal metabolic
    rate and diet-induced thermogenesis in Asians
    living in Britain’.Hum. Nutr. Clin. Nutr. 41 (5):
    397–402.
    Hess EV. 1982. ‘Drug-related lupus’.Arthritis Rheum.
    25 (7).
    Homma M. 1991. ‘Ministry of Health and Welfare
    Report’. InProceedings of First International Con-
    ference on Harmonization, ICH-I, Brussels.
    Jefferson JW, Ackerman DL, Carol JA, Greisi JH. 1987.
    Lithium Encyclopedia for Clinical Practice.Amer-
    ican Psychiatric Press: Washington, DC.
    Kalow W. 1989. ‘Race and therapeutic drug response’.
    N. Engl. J. Med. 320 : 588–589.
    Kato H, Tillotson J, Hamilton HB, Nichaman MZ,et al.,

  2. ‘Epidemiologic studies of coronary heart dis-
    ease and stroke in Japanese men living in Japan,
    Hawaii and California’.Am. J. Epidemiol. 97 (6):
    372–385.
    Khandker R, Simoni-Wastilia LJ. 1998. ‘Differences in
    prescription drug utilization and expenditures
    between Blacks and Whites in the Georgia Medicaid
    population’.Inquiry 35 (1): 78–87.
    Kiowiski N, Bolli P, Bu ̈hler FR, Ernep P,et al., 1985.
    ‘Age, race, blood pressure, and renin predictions for
    hypertensive treatment with calcium antagonist’.
    Am. J. Cardiol. 16 : 81H–85H.
    Kumana CR, Chan M, Ko W, Lauder J, Lin HJ. 1987.
    ‘Differences in diazepam pharmacokinetics in Chi-
    nese and White caucasians: relationship to body
    lipid stores’.Eur. J. Clin. Pharmacol. 32 : 211–215.
    Kupfer A, Preisig R, Zeugin T. 1988. ‘Pharmacogenetic
    aspects of biological variability’.J. Gastroenterol.
    Hepatol. 3 : 623–633.
    Leiberman JA, Canoso RT, Egea E, Kane JM, Yunis J.

  3. ‘HLA-B38, DR4, DQW3 and clozapine-induced


246 CH18 RACIAL AND ETHNIC ISSUES IN DRUG REGISTRATION

Free download pdf