Principles and Practice of Pharmaceutical Medicine

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17 Clinical Research in Children Lionel D. Edwards 17.1 Background The world population reached 6 billion in June 2000, and half ...

These additional costs for pediatric studies may be justified if these studies satisfy all global mar- kets. MacLeod (1991) esti ...

data were still needed for pediatric labeling. The FDA has issued an annual list of ‘priority drugs’ for which additional pediat ...

Most infants are slow acetylators and may accumulate toxic levels of those drugs that are metabolized by this second phase of me ...

numbering 13 units. There are other non-govern- mental specialized units also available for pediatric PK work. An alternative me ...

IRBs’ special emphasis IRBs have a duty to make sure the study is of value to children in general and in most cases to the patie ...

Finaly, the inclusion of the needs of children in clinical trials, as envisioned by the then FDACom- missioner, Dr Charles Edwar ...

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18 Racial and Ethnic Issues in Drug Registration LionelD.Edwards,J.M.Husson,E.Labbe ́,C.Naito,M.PapalucaAmati, S. Walker, R. Wil ...

To date, it is by no means clear that harmoniza- tion has reduced the overall burden of regulations for either the regulators or ...

have local clinical data developed, it did not appear that actual regulations precluded the use of ‘foreign’ (usually US) data i ...

associated with high levels of Von Willebrand fac- tor (Folsomet al., 1999), found commonly in the Black population sickle cell ...

Some drugs, such as phenothiazines and tricyclic antidepressants, show greater preference for bind- ing and transport ona–1 acid ...

events at lower doses than Caucasians, even after body weight was accounted for (Lin, 1986: 1991; Wood and Zhou, 1991). With tri ...

differences in medical practice. The type and frequency of adverse reactions observed during clinical trials was generally lower ...

Ethnic variations in diet, additives or salt content may alter metabolism rates. Linet al.(1986) and Henryet al.(1987) report th ...

per capita is twice as great in the United States compared to the United Kingdom, and four times more than in Germany. Caesarian ...

reporting framework and regulatory requirements, but qualitatively, the same serious adverse events were reported appropriately ...

(Davitz and Davits, 1981), that Jews, Hispanics and Italians appear to suffer more than Germans, Anglo-Saxons and Asians, but su ...