Tagged with: Clinical trials

Post Authorization Safety Studies (PASS)

Studies performed after a product has been placed on the market is called Post Authorization Studies and those that have a primary safety objective is called Post Authorization Safety Studies. This is the general definition but very specific meanings can be associated with these terms in individual countries and regions like the US or the European Union...

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Clinical trial design

There are many definitions of clinical trials, they are generally considered to be medical or health-related research studies in human beings that follow a pre-defined protocol.

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Clinical trial history

Clinical trials concept is very old dating back to before 1025 AD, but in the form used today the first description started around 1750

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Clinical trial phases

Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

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Drug Safety Introduction

Costs of illness due to adverse effects of drugs is estimated to 117.4 billion ($ 117.400.000.000) in 2000 for the United States alone (Ernest and Grizze, 2001). It is hard to comprehend the magnitude of this number, but it is only the financial side of the problem. It is estimated that up 98.000 American die every year due to drug related events an unknown number of patients experience additional suffering and injuries (2).

Inspection Checklist

The drug safety function needs to be continuously ready for inspections by the authorities. A wide range of items have to be considered and documented before an inspection. The details are described in this article.

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