Clinical trials

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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 [...]

15 04, 2014

Is Risk Based Monitoring Appropriate for MENA?

By | 2016-10-12T14:35:11+00:00 April 15th, 2014|Categories: News|Tags: , , , , , |

A recent article in the Journal of Clinical Studies Volume 6, issue 2, 2014* discussed the applicability of new FDA and EMA recommendations for risk-based monitoring. Knowing that greater than 30 per cent of a clinical budget is allocated to cover monitoring costs and more than 50 per cent of that is spent on source document verification (SDV), risk-based monitoring allows companies to more effectively target and prioritize resources around [...]

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 [...]

24 01, 2013

Enrichment Strategies for Clinical Trials

By | 2016-10-12T14:35:11+00:00 January 24th, 2013|Categories: News|Tags: , , , , , , , , , |

Author: Steve Kates, Ph.D. A draft guidance has recently been issued (Dec 2012) entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” The document required more than 6 years to prepare and provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims. This guidance outlines three enrichment strategies. 1. Strategies to decrease heterogeneity [...]

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 [...]