Oncology studies

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21 04, 2014

Conducting BA/BE Studies in The Middle East and North Africa (MENA)

By | 2016-10-12T14:35:11+00:00 April 21st, 2014|Categories: News|Tags: , , , , , , , , , , , |

Bioavailability (BA) and Bioequivalence (BE) studies are important for both marketing generic products and developing a new chemical entity.  For the former, these are the quintessential studies required for approval.  The potential to-be-marketed generic product (test product) is examined against a commercially-available brand product (reference product) under the same molar dose and under similar conditions to confirm that the mean plasma concentration over time is comparable.  Key pharmacokinetic parameters examined [...]

16 03, 2014

Rising Value of Conducting Clinical Trials in MENA

By | 2016-10-12T14:35:11+00:00 March 16th, 2014|Categories: News|Tags: , , , , , , |

The key benefit of clinical trials globalization is faster time to market.  The MENA region is an attractive region due to its high population, growing biopharmaceutical market, and low number of clinical trials. The MENA region has 21 countries covering a surface of over 15 million square kilometers and has a population of 381 million people; about 6% of total world population, yet only less than 1% of all clinical [...]

15 09, 2011

Including patients with brain tumors in phase I oncology trials?

By | 2016-10-12T14:35:11+00:00 September 15th, 2011|Categories: News|Tags: , , |

Recently Wen* and his colleagues made a case in JCO for why patients with brain tumors should be included in phase I clinical trials. They are argued that most of the reasons that led to the exclusion of these patients in the past were obsolete and should be reconsidered. Below is a summary on why these patients should be considered for phase I trials. They are no longer treated with [...]