Principles and Practice of Pharmaceutical Medicine

results are restricted to statements regarding the specific patient populations studied and the sample sizes available (see abov ...

CIOMS Working Group VI. 2005.Management of Safety Information from Clinical Trials.CIOMS: Geneva. Collins GE, Clay MM, Falletta ...

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40 Data Mining Mirza I. RahmanandOmar H. Dabbous Data mining has been defined as ‘The nontrivial extraction of implicit, previou ...

analysts and healthcare professionals with the abil- ity to assess the validity of the results generated by a data mining algori ...

been in the market for a long time and may have a lot of AE reports in the database) and/or the larger the number of cases of a ...

associations and do not necessarily imply a clinical or a causal association. As discussed, there are several disproportional- i ...

Some of the limitations of the FDA’s AERS database are that the lag time can be several months, there is underreporting and ther ...

gray, which represents low disproportionality, that is the observed frequency is not substantially dif- ferent from the expected ...

informational sources as needed. A case series of rhabdomyolysis associated with cerivastatin could have been constructed and an ...

regulatory action can influence the rate of reporting as well as the types of events reported. In addition, this database can co ...

coding and the lack of ex-US, serious, labeled reports, making this an invalid comparison. Since the signaling data sources are ...

interest (e.g. results from preclinical, clinical, pharmacoepidemiologic or other available studies). Data mining techniques sho ...

broad perspective to a fine focus, this ability for the user to ‘drill down’ to the level of detail in which he/she is intereste ...

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41 Risk Management in Product Approval and Marketing Anthony W. Fox 41.1 What is it? In general terms: Identification and imple ...

more frequently in the early part of the product life cycle than later on. The least restrictive ordinary situation is when clin ...

view; for example, expressing concern about special programs that drive product costs upward and when these costs are absorbed b ...

management programs. Most countries recognize the need for four or five degrees of scheduling with graded increases in product r ...

provided by orphan drug status. This might be a rare situation where the toxicology of an orphan drug product is well known due ...