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Ethical Considerations in the Conduct of Clinical Pharmacokinetic Studies

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References

  • Atiba JO, Taylor G, Pershe RA, Blaschke TF. Plasma antipyrine half-life can be determined from urine data. British Journal of Clinical Pharmacology 23: 715–719, 1987

    Article  PubMed  CAS  Google Scholar 

  • Beauchamp TH, Childress JF. Principles of biomedical ethics, Oxford University Press, New York, 1979

    Google Scholar 

  • Danhof M, Breimer DD. Therapeutic drug monitoring in saliva. Clinical Pharmacokinetics 3: 39–57, 1978

    Article  PubMed  CAS  Google Scholar 

  • Fraser HS, Mucklow JC, Murray S, Davies DS. Assessment of antipyrine kinetics by measurement in saliva. British Journal of Clinical Pharmacology 3: 321–325, 1976

    Article  PubMed  CAS  Google Scholar 

  • James A, Koren G, Milliken J, Soldin S, Prober C. Vancomycin pharmacokinetics and dose recommendations for preterm infants. Antimicrobial Agents and Chemotherapy 31: 52–54, 1987

    Article  PubMed  CAS  Google Scholar 

  • Kinney EL, Trautmann J, Gold JA, Vesell ES, Zelis R. Under-representation of women in new drug trials: ramifications and remedies. Annals of Internal Medicine 95: 495–499, 1981

    PubMed  CAS  Google Scholar 

  • Koren G, James A. Vancomycin dosing in preterm infants: prospective verification of new recommendations. Journal of Pediatrics 110: 797–798, 1987

    Article  PubMed  CAS  Google Scholar 

  • Koup JR, Sack CM, Smith AL, Gibaldi M. Hypothesis for the individualisation of drug dosage. Clinical Pharmacokinetics 4: 460–469, 1979a

    Article  PubMed  CAS  Google Scholar 

  • Koup JR, Slattery JT, Gibaldi M. Single point clearance estimation. Research Communications in Chemical Pathology and Pharmacology 25: 559–564, 1979b

    PubMed  CAS  Google Scholar 

  • Levine RJ. Ethics and regulation of clinical research, 2nd ed., Urban & Schwarzenberg, Baltimore-Munich, 1986

    Google Scholar 

  • Long D, Koren G, James A. Ethics of drug studies in infants: how many samples are required for accurate estimation of pharmacokinetic parameters in neonates? Journal of Pediatrics 111: 918–921, 1987

    Article  PubMed  CAS  Google Scholar 

  • Meffin PJ, Williams RL, Blaschke TF, Rowland M. Application of salivary concentration data to pharmacokinetic studies with antipyrine. Journal of Pharmaceutical Sciences 66: 135–137, 1977

    Article  PubMed  CAS  Google Scholar 

  • Mirkin BL. Drug therapy and the developing human: who cares? Clinical Research 23: 106–113, 1975

    PubMed  CAS  Google Scholar 

  • Saeed MA, Gatens PF. Anterior interosseous nerve syndrome: unusual etiologies. Archives of Physical Medicine and Rehabilitation 64: 182, 1983

    PubMed  CAS  Google Scholar 

  • Schafer A. The ethics of the randomized clinical trial. New England Journal of Medicine 307: 719–724, 1982

    Article  PubMed  CAS  Google Scholar 

  • Svensson CK. Is blood sampling for determination of antipyrine pharmacokinetics in healthy volunteers ethically justified? Clinical Pharmacology and Therapeutics 44: 365–368, 1988

    Article  PubMed  CAS  Google Scholar 

  • Svensson CK. Representation of American Blacks in clinical trials of new drugs. Journal of the American Medical Association 261: 263–265, 1989

    Article  PubMed  CAS  Google Scholar 

  • Taylor G, Blaschke TF. Measurement of antipyrine half-life from urinary drug concentrations. British Journal of Clinical Pharmacology 18: 650–652, 1984

    Article  PubMed  CAS  Google Scholar 

  • Van Boxtel CJ, Wilson JT, Lindgren S, Sjöqvist F. Comparison of the half-life of antipyrine in plasma, whole blood and saliva of man. European Journal of Clinical Pharmacology 9: 327–332, 1976

    Article  PubMed  Google Scholar 

  • Vesell ES, Passananti GT, Glenwright PA, Dvorchik BH. Studies on the disposition of antipyrine, aminopyrine, and phenacitin using plasma, saliva, and urine. Clinical Pharmacology and Therapeutics 18: 259–272, 1975

    PubMed  CAS  Google Scholar 

  • Welch RM, De Angelis RL, Wingfield M, Farmer TW. Elimination of antipyrine from saliva as a measure of drug metabolism in man. Clinical Pharmacology and Therapeutics 18: 249–258, 1975

    PubMed  CAS  Google Scholar 

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Svensson, C.K. Ethical Considerations in the Conduct of Clinical Pharmacokinetic Studies. Clin-Pharmacokinet 17, 217–222 (1989). https://doi.org/10.2165/00003088-198917040-00001

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