Chapter References

1. Horton, L.R., Chao, P., Dempsey, W., and Flamm, E. (1997). International harmonization of the regulation of drugs and biologics. In Fundamentals of law and regulations (ed. D.G. Adams, F.M. Cooper, and J.S. Kahan), Vol. 2, pp. 437-554. Food and Drug Law Institute, Washington, DC.

2. Holmes, O.W. (1891). Medical essays, 1842-1882. Cited by J.H. Young. Mercury, meat and milk. Pure food: securing the Federal Food and Drugs Act of 1906, pp. 18-39. Princeton University Press, 1989.

3. Hoffman, J.E. (1997). Administrative procedures of the FDA. In Fundamentals of law and regulations (ed. D.G. Adams, F.M. Cooper, and J.S. Kahan), Vol. 2, pp. 13-53. Food and Drug Law Institute, Washington, DC.

4. Jackson, C.O. (1970). Much power to your elbow. Food and drug legislation in the new deal, pp. 126-30. Princeton University Press.

5. Jackson, C.O. (1970). Doctor Massengill's elixir. Food and drug legislation in the new deal, pp. 151-74, Princeton University Press.

6. Brady, R.P. and Kracov, D.A. (1991). From diphtheria antitoxin to cytokine products: a remarkable scientific journey/an aging regulatory framework. Regulatory Affairs, 3, 105-32.

7. Hrobjartsson, A., Gotzsche, P.C., and Gluud, C. (1998). The controlled clinical trial turns 100 years: Fibiger's trial of serum treatment of diphtheria. British Journal of Medicine, 317, 1243-5.

8. Doll, R. (1998). Controlled trials: the 1948 watershed. British Medical Journal, 317, 1217-20.

9. Silverman, M. and Lee, P.R. (1974). Drug efficacy: the case of the emperor's old drugs. Pills, profits and politics, pp. 107-137. University of California Press, Berkeley, CA.

10. Silverman, M. and Lee, P.R. (1974). The impossible dream: search for the absolutely safe drug. Pills, profits and politics, pp. 81-106. University of California Press, Berkeley, CA.

11. Code of Federal Regulations Title 21: Parts 300-499, 1 April 1998.

12. Anonymous (1948). The controlled therapeutic trial. British Medical Journal, ii, 791-2.

13. Leber, P.D. and Davis, C.S. (1998). Threats to the validity of clinical trials employing enrichment strategies for sample selection. Controlled Clinical Trials, 19, 178-87.

14. Leber, P.D. (1989). Hazards of inference: the active control investigation. Epilepsia, 30 (Suppl. 1), S57-63.

15. Model, W. and Houde, R. (1959). Factors influencing clinical evaluation of drugs. Journal of the American Medical Association, 167, 2190-9.

16. Leber, P.D. (1992). Postmarketing surveillance of adverse drug effects. In Adverse effects of psychotropic drugs (ed. J. Lieberman and J. Kane), pp. 3-12. Guilford Press, New York.

Pregnancy And Childbirth

Pregnancy And Childbirth

If Pregnancy Is Something That Frightens You, It's Time To Convert Your Fear Into Joy. Ready To Give Birth To A Child? Is The New Status Hitting Your State Of Mind? Are You Still Scared To Undergo All The Pain That Your Best Friend Underwent Just A Few Days Back? Not Convinced With The Answers Given By The Experts?

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