Principles and Practice of Pharmaceutical Medicine
product can be marketed at a lower price than the innovator. In the special case of generic products, at the very end of a drug’ ...
The finding of a new, nonobvious use for an old drug can also be patented. This type of patent is known as a ‘Method of Use’ pat ...
some interactions. Many PLA/NDAs will contain studies of particular drug interactions that seem relevant at the time, especially ...
However, when anything new is discovered about a drug in phase IV, then, by definition, it will not be in the product label. Fur ...
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11 Site Management Barry Miskin The investigative site serves a critical function in the clinical development process. As the ph ...
contract negotiation, accounting and patient recruitment services. With more than one-third of US-based clinical trials taking p ...
data management and increaseduse ofelectronic data capture (EDC) accommodation for record storage Clinical investigator The cl ...
Study coordinator The study coordinator is generally considered the linchpin in the day-to-day activities of clinical research. ...
For small or part-time sites that cannot justify a full-time DCO, a well-trained coordinator can assume this function. Quality a ...
credentials of investigators and sub-investigators, adverse event reporting and participation in site inspections are some of th ...
requiring suspected serious unexpected adverse reactions (SUSARs) be reported electronically to Eudra Vigilance, the European da ...
industry’s key bottlenecks. Data suggest that in North America, for example, more than 90% of clinical trials must extend the en ...
the cost of processing, packing and shipping the samples to a central laboratory; supplies and equipment needed to conduct the ...
Theinvestigator-orientedinspection is initiated for several reasons. Some include: the investigator conducted a study that is pi ...
entails keeping metrics of on time completion of patient recruitment and enrollment, retention rates of study volunteers, succes ...
Neuer A. 2003. Treating study volunteers as customers. CenterWatch 10 (3). 2004 Report to the Nation Improving Public Health Thr ...
12 Good Clinical Practices Wendy BohaychukandGraham Ball The aim of this chapter is to describe the general framework for conduc ...
results, the whole process should be transparent, that is everything must be documented so that an external reviewer may verify ...
will not be harmed. Some companies report that, in practice, they have little choice in this process, as the marketing departmen ...
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