Principles and Practice of Pharmaceutical Medicine
anti-acne preparations, most of which are of little safety concern but can produce very substantial irritation. However, the eff ...
concerned with detailed issues of formulation and manufacturing. Because staff are fewer and the hierarchy sim- pler, the OTC cl ...
and labeling statements, a compound may be for- mulated and marketed on the judgment of the Sponsor alone. No further pre-approv ...
This role is greater in scope and responsibility in the OTC area and everything must be done with greater speed. 14.4 Prescripti ...
When starting with a prescription-only medi- cine, it is extremely important to begin interac- tions with the regulatory agencie ...
new chemical entity development, to programs consisting of little more than a single study. What influences the basic size and e ...
Actual use studies are often called ‘slice-of-life’ studies. In the real world, what will this OTC product do? It helps when inc ...
meaningfultopatients,eventhoughtheymayappear minor to the pharmacologist, who is not actually using the drug him/herself. For ex ...
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SECTION III Special Populations and Required Special Studies Introduction In 1993, the US Food and Drug Administration (FDA), Eu ...
costs of additional research would add to the already enormous cost of drug and devices research. Second, the ever-present fear ...
15 Drug Research in Older Patients Lionel D. Edwards 15.1 Demographics The elderly (over 64 years old) comprise 12% of the US po ...
academic research aimed at improving the quality of life and the prolongation of active old age. It will be interesting to see w ...
prescribing accounted for 19–36% of hospital admissions due to drug-related adverse events. To compound this worrying situation, ...
adverse events by age. In addition, other studies should determine whether older people handle the new drug differently (a 30% d ...
are given as examples. Finally, other common drugs most likely to be used with the test drug are recommended to be explored for ...
thrombolytics in case of cerebral thrombosis. As of 1999, more than 20new drugs were in development to treat this condition. Art ...
Theelderlyaremorelikelytohavecognitiveimpair- ment or mild dementia, and to be living alone, in poverty or under institutional c ...
Nearly 450 000 patients were screened (SHEP Cooperative Research Group, 1991). Hall (1993) reported on 15 cardiovascular stu- di ...
Federal Register. 1999. ‘Guidelines for the study of drugs likely to be used in the elderly’.Federal Register, March 55 FR; 7777 ...
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