The Problem of Special Populations and Issues of Safety and Efficacy for Drug Registration

  • D. R. Laurence
Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)


It is sensible that therapeutic trials of a new drug should be conducted on patients having the disease(s) concerned, but with as few complicating factors as possible. This is because the first priority must be to discover whether the drug is capable of giving benefit and to do this as quickly and as clearly as is practicable.


Special Population Data Sheet European Economic Community Positive Duty Creatinine Clearance Rate 
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    L.E. Ramsey, Drugs in breast milk, in Topics in Therapeutics 6. H.F. Woods, ed., Royal College of Physicians of London, Pitman Medical, Tunbridge Wells (1980)Google Scholar
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    L.C.K. Low, J. Lang, andW.D. Alexander, Excretion of 84 carbimazole and propylthiouracil in breast milk, Lancet, 2: 1011 (1979)PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 1981

Authors and Affiliations

  • D. R. Laurence
    • 1
  1. 1.Department of Clinical PharmacologySchool of Medicine, University College LondonLondonUK

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