Principles and Practice of Pharmaceutical Medicine

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16 Drug Development Research in Women Lionel D. Edwards 16.1 Background The pharmaceutical industry is in the business of develo ...

from 2000 to 2050, compared to males (45.4%). Population of women over 65 years will increase by 24% over 2000–2010 in the Unite ...

findings ofno differencesare rarely reported, but sometimes this finding may just be a function of small sample size for each in ...

16.3 The phantom fetus Teratogenic issues The term ‘phantom fetus’ has been used to describe the current apprehension regarding ...

devices, for many experimental drugs (perhaps 9 out of 10 tested in man) will never achieve the marketplace. The potential for p ...

the incidence of anticonvulsant teratogenic effects are increased (Lindhautet al., 1984). Would either of these drugs be develop ...

adverse effects; also, information on ‘target organs’ (organs likely to be most affected or harmed) is usually predictable but u ...

frequentlyyoung peopleofcollegeage. Bothmales and females will volunteer as financial remunera- tion, and a free medical check-u ...

a low toxicity ceiling (e.g. digoxin) where adjusted dosing is required. The weight/dose problem A casual appraisal of ideal wei ...

plasma levels of propranolol than men following single oral dosing and, in an additional study, showed that on multiple dosing, ...

the greatest users of these medications, should not study recruitment members be biased in their favor? However, some of the psy ...

The FDA issued new guidelines in 1993 (Federal Register, 1993), perhaps spurred by its own find- ings in 1989, and confirmed by ...

FDA or by industry. However, only 10 companies (30%) frequently or usually collected data on men- strual cycle; 56% replied that ...

significant percentage loss or enhancement of effi- cacy, for example 30%, dependent on the disease or symptoms. Representative ...

and these hormone concentrations (10–20 times higher than the natural hormone levels) may cause drug interactions which cannot o ...

insignificant. Theoretically, because of weight dif- ferences, women may receive more medication than men for a standard dose wh ...

Booth M, Hunt JN, Miles JM, Murray FA. 1957. Comparison of gastric emptying and secretion in men and women with reference to pre ...

Kristensen CB. 1983. Imipramine serum protein bind- ing in healthy subjects.Clin. Pharmacol. Ther. 34 : 689–694. LaRosa GH, Pinn ...

Smith JM, Baldessarini RJ. 1973. Changes in preva- lence, severity and recovery in tardise dyskinesia with age.Arch. Gen. Psychi ...