CRO

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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 [...]

11 01, 2013

How will be the impact on clinical trials in India for 2013?

By | 2016-10-20T17:41:24+00:00 January 11th, 2013|Categories: News|Tags: , , , , , , , |

Reference: FierceCRO | 01.07.13 | Indian court: Trials wreaking 'havoc Indian Supreme Court: Unregulated trials causing 'havoc' The clamor for reform of India's clinical trial regulations has reached a fever pitch over the past year, and now the country's Supreme Court is ordering the Health Ministry to keep a close eye on applications for new studies. The court heard a case claiming that many patients around the country were [...]