Principles and Practice of Pharmaceutical Medicine
Quite apart from these general trends blurring the distinctions between phases I, II and III, there are (and always have been) s ...
to interpret the results. Although the finer points of statistics are presented elsewhere in this book, it is common sense that ...
findings among ‘selected secondary end points’). A sound interpretation, of course, is based upon only those end points that wer ...
6000-odd admissions were for scurvy). He subse- quently developed a large private practice, but little fame amongst his peers, a ...
9.8 Objectives and prerequisites of phase II studies Gallenical forms A good rule of thumb is that pivotal clinical trials for r ...
tolerability may be dose-dependent, and this can only be assessed when studied in a systematic fashion. Lastly, most drugs are j ...
exhaustive, because almost all clinical trials are different. What follows is an attempt to briefly review the classes of clinic ...
procedure in reverse, although may be conducted open-label and more rapidly (guided by suitable PK information) than when therap ...
remembered that continuous responses can be con- verted into quantal responses with appropriate, prospective efficacy criteria. ...
development team to detect drug toxicity early, but not efficacy. Similarly, depending upon the hypoth- eses under test, control ...
Stratification studies In pivotal studies, large numbers of patients are studied so that their diverse clinical characteristics ...
the natural progression of disease is unknown, then it can be ethical to recruit patients into a study with inclusion criteria t ...
regulatory authorities have a habit of believing only the most conservative. At the time of writing, the O’Brien and Fleming rul ...
as a matter of routine, might occasionally lead to a superior trial design. 9.15 Series of published cases Some diseases are so ...
answers to the clinical trial questions were known, then there would be little point in doing the trial. There are highly mathem ...
and after continuous infusion of remifentanil or alfentanil.J. Pharmacol. Exp. Ther. 274 : 34–39. Bardolph EM, Taylor RH. 1997. ...
...
10 Phase IV Drug Development: Post-Marketing Studies Lisa R. Johnson-Pratt 10.1 Objectives of the phase IV clinical development ...
of the nuances and challenges of conducting phase IV trials. The type of investigator that one seeks during phase IV development ...
meta-analytical comparisons of placebo-controlled studies of different drugs, which were conducted at different times and in dif ...
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