Booth M, Hunt JN, Miles JM, Murray FA. 1957.
Comparison of gastric emptying and secretion in
men and women with reference to prevalence of
duodenal ulcer in each sex.Lancet 1 : 657–659.
Bush JK, Cook SF, Seigel E. 1993. Issues of special
populations in drug developments.Drug Inf. J. 27 :
1185–1193.
Chen, ML, Lee, SC, Ng, MJ,et al.2000. Pharmacoki-
netic analysis of bioequivalence trials for sex related
issues in clinical pharmacology and biopharmaceu-
ticals.Clin. Pharmacol. Therapeut. 68 (5): 510–521.
Clark AF, Calandra RS, Bird CE. 1971. Binding of
testosterone and 5-dihydrotestosterone to plasma
protein in humans.Clin. Biochem. 4189–4196.
Coale AJ. 1991. Population and development review.
J. Popul. Counc. NY.
Coles SL, Fries JF, Kraines RG, Roth SH. 1988. Side
effects of non-steroidal antiinflammatory drugs.Am.
J. Med. 74 : 820–828.
Conrad CD, Hamilton JA. 1986. Recurrent premenstr-
ual decline in lithium concentration: clinical corre-
lates and treatment implications.J. Am. Acad. Child
Psychiatr. 26 (6): 852–853.
Cotton P. 1990. Medical news and perspective.J. Am.
Med. Assoc. 263 (8): 1049–1050.
Cramer JA, Scheyer RD, Mattson RH. 1990. Compli-
ance declines between clinic visits.Arch. Intern.
Med. 150 : 1509–1510.
Diokno SC, Brock BM, Brown MB, Hertzog AR. 1986.
Prevalence of urinary incontinence and other urolo-
gical symptoms in non-institutionalized elderly.
J. Urol.B6: 1022–1025.
Divoll M, Greenblatt DJ, Harmatz JS, Shader RI. 1981.
Effect of age and gender on disposition of temaze-
pam.Pharm. Sci. 70 : 1104–1107.
Ebert SN, Liu XK, Woolsley RL. 1998. Female gender
as a risk factor for drug-induced cardiac arrythmias:
evaluation of clinical and experimental evidence.
J. Womens Health 7 : 547–557.
Edwards LD. 1991. Summary of survey results on
including women in drug development. PMA. In
Development Series, New Medicines for Women,
December 1991; 22–28.
Elia J, Katz IR, Simpson GM. 1987. Teratogenicity of
psychotherapeutic medications.Psychopharmacol.
Bull. 23 : 531–586.
FDA. 1986.Drug Utilization in the US 1986—Eighth
Annual Review.Washington, DC: FDA.
Federal Register. 1990. Guideline for study of drugs
likely to be used in the elderly.Fed. Reg. 55 :FR
7777; (1997) Labeling: subsection, geriatric use. 21
CFR Pt 201.
Federal Register. 1994. Detection of toxicity to repro-
duction for medicinal products. ICH Guideline SSA
(59 Fed Reg: 48746).
Federal Register. 1996. Detection of toxicity to repro-
duction for medicinal products. Addendum an toxi-
city to male fertility. ICH Guideline 553 (61 Fed
Reg: 15360).
Federal Register. 1993. Guideline for the study and
evaluation of gender difference in the clinical eva-
luation of drugs (58 Fed Reg: 39406–16).
Frederick J. 1973. Epilepsy and pregnancy: a report
from the Oxford Record Linkage Study.Br. Med.
J.ii: 442–448.
Frezza M, DiPadova C, Pozzato G,et al.1990. High
blood alcohol levels in women. The rate of
decreased gastric alcohol dehydrogenase activity
and first-pass metabolism.N. Engl. J. Med. 322 :
95–99.
Gengo FM, Fagin SC, Kinkel WR, McHugh WB. 1984.
Serum concentrations of propranolol and migraine
prophylaxis.Arch. Neurol. 41 : 1306–1308.
Greenblatt DJ, Divoll M, Harmatz JS, Shader RI. 1980.
Oxazepam kinetics: effects of age and sex.J. Phar-
macol. Exp. Ther. 215 : 86–91.
Greenblatt DJ, Harmatz JS, Shader RI. 1979. Sex
differences in diazepam protein binding in
patients with renal insufficiency. Pharmacology
16 : 26–29.
Halbreich U,Carson SW. 1989. Drugstudies inwomenof
childbearing age: ethical and methodological consid-
eration.J. Clin. Psychopharmacol. 9 : 328–333.
Health Care Financing Administration US Health and
Human Services. http://www.hcfa gov/stats/stats.htm.
Henrekens CH,et al.1989. Steering Committee of the
Physicians Health Study Research Group Final
report on the aspirin component of the ongoing
Physicians Health Study. N. Engl. J. Med. 321 :
129–135.
Holden A (2000) New medicines in development for
women: a 1999 survey. Pharmaceutical research and
manufacturers association. www pharma .org/pdfwq
pdf 29–36.
Holmer A, 2004. Survey medicines in development for
women.
International Conference on Harmonization. 2004.
Gender conciderations inthe conduct of clinical trials.
Regional Experience, November 2004. http://www. ICH.org/
Url GrpServer.jser?@ID¼276 ¢@Template¼245.
Jefferson JW, Greist JH, Ackerman DL (eds.). 1987.
Lithium Encyclopedia for Clinical Practice. 2nd
edition. American Psychiatric Press: Washington,
DC; 640–645.REFERENCES 219