Principles and Practice of Pharmaceutical Medicine

isoenzymes simultaneously. Barbiturates (barbi- tals), rifampicin and cigarette smoking are all well-known enzyme inducers, and ...

20.5 Regulatory considerations of drug interactions This chapter has concentrated on drug interaction studies during the develop ...

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21 Orphan Drugs 1 Bert Spilker 21.1 Introduction In the United States, ‘rare disease’ is defined as a disease with a prevalence ...

new drug is preferable for a company. However, there are some exceptions to this rule, depending on the degree of patent coverag ...

Are alternative treatments available? The competitive position of the disease area must be considered. There are several catego ...

4.Unprofitable drug for a common disease. This category of drug is described in the orphan drug legislation and could refer to t ...

Patients and families The motivation of those with the disease or those with relatives with the disease is clear – they want bet ...

directly to institutions. Orphan drugs more often use what are referred to as alternative distribu- tion techniques. These inclu ...

will have much less pressure to approve the more common indication when the NDA is sub- mitted and approved for the orphan indic ...

already the drug of choice for that disease and that everyone was already using it and that it would even possibly be viewed as ...

Established the Orphan Products Board within the US government. Allowed tax credits for certain expenses in clin- ical trials. ...

This would provide a wide variety of benefits to a company, including the stimulation of staff who recognize the medical importa ...

21.15 Establishing differences among medicines It is often important to establish that a company’s medicine for which it desires ...

21.17 Rating the effects of the Orphan Drug Act in the United States With over 650 active designations and over 120 orphan drugs ...

SECTION IV Applied Aspects of Drug Development Introduction Having covered in Sections I and II the strictly clinical, more orth ...

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22 Biotechnology Products and Development David A. ShapiroandAnthony W. Fox 22.1 Introduction The objectives of this chapter are ...

using biotechnology products will not be covered, although they could be classed as biological pro- ducts. Similarly, pluripoten ...

‘Fast Track’designations for accelerating review and approval However, in the United States, illogicalities still persist. For ...