Principles and Practice of Pharmaceutical Medicine

(Elle) #1

Finaly, the inclusion of the needs of children in
clinical trials, as envisioned by the then FDACom-
missioner, Dr Charles Edwards, in 1972 to the
American Academy of Pediatrics is almost ful-
filled, albeit after 34 years.


References


Abramson VS, Meisal A, Sufar P. 1986 ‘Deferred consent



  • a new approach for resuscitation research on
    comatized patients’.J. Am. Med. Assoc. 225 : 2466–



  1. Arant BS. 1978. ‘Developmental patterns of renal
    function maturation compared to the neonate’.
    J. Pediatr. 92 : 705–712.
    American Academy of Pediatrics, Committee on Drugs.

  2. ‘Guidelines for the ethical conduct to evaluate
    drugs in pediatric populations’.Pediatrics 95 : 286–


  3. FDA. 1997.Food and Drug Administration Moderniza-
    tion Act(Pub. Law 105–115), 21 November, USDC
    355a, 111 Stat. 2296.
    Federal Register. 1983. 16d.
    Federal Register. 1994. ‘Specific requirements on con-
    tent and format of labeling for human prescription
    drugs revision of ‘pediatric use’ subsection in the
    labeling’.Federal Register 59 (238): 64240–64250.
    Federal Register. 1998. ‘Final rule regulations requiring
    manufacturers to assess the safety and effectiveness
    of new drugs and biological products in pediatric
    patients’.Federal Register 63 : 66632.
    Federal Register. 2000. ‘International Conference on
    Harmonization: clinical investigation of medicinal
    products in the pediatric population’. Federal
    Register 65 (71).




Gilman JT, Gal P. 1992. ‘Pharmacokinetic and pharma-
codynamic data collection in children and neonoates’.
Clin. Pharmacokinet. 23 :1–9.
Holmer AF. 2004. ‘Survey or new medicines in chil-
dren’. Pharm. Res. Manufact. Am. (http://
http://www.phrma.org).
MacLeod SM. 1991. ‘Clinical pharmacology and opti-
mal therapeutics in developing countries: aspirations
and hopes of the pediatric clinical pharmacology
subcommittee’.J. Clin. Epidemiol. 44 (Suppl. II):
89–93.
Miller telephone interview. 1997. Script No. 2260, 22
August 1997.
National Center for Health Statistics. 1996. Based on
data from US Department of Health and Human
Services.
Pina LM. 1995. ‘Drugs widely used off-label in pedia-
trics’.Report of the Pediatric Use Survey Working
Group of the Pediatric Subcommittee.
Rane A. 1992. ‘Drug disposition and action in infants
and children’. InPediatric Pharmacology, Thera-
peutic Principles in Practice, Yaffe SJ, Arand AJV
(eds). Sanders: New York; 10–12.
Signer E, Fridrich R. 1975. ‘Gastric emptying in new-
borns and young infants’.Acta Paediatr. Scand.64:
525–530.
Stewart GF, Hampton EM. 1987. ‘Effect of maturation
on drug deposition in pediatric patients’. Clin.
Pharm. 6 : 548–564.
Still JG. 2000. ‘The pediatric research initiative in the
United States: implications for global pediatric
research’.Drug Inf. J. 35 : 207–212.
Wilson JT. 1975. ‘Pragmatic assessment of medicines
available for your children and pregnant or breast-
feeding women’. InBasic Therapeutic Aspects of
Perinatal Pharmacology, Morsell PL, Garattini S,
Serini F (eds). Raven: New York.

REFERENCES 229
Free download pdf