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3 06, 2016

The Middle East and North Africa : a highly under-represented region for clinical studies

By | 2016-10-12T18:01:50+00:00 June 3rd, 2016|Categories: News|

C. Habita at ARIANNE explores clinical trials in the Middle East and North Africa, and explains why these areas should not be neglected in favour of more familiar countries.

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Author: Steve Kates, Ph.D. A draft guidance has recently been issued (Dec 2012) entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.”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 [...]

1 11, 2011

5 tips for a working relationship between a Sponsor and CRO

By | 2016-10-12T14:35:11+00:00 November 1st, 2011|Categories: News|

The working relationship between a Sponsor and CRO is dynamic, fluid and ever changing. It is often one of the most crucial decisions a Sponsor needs to make when assessing their clinical and regulatory path in new drug development. Why is it, that like a marriage, some CROs and Sponsors ‘click’ immediately and others face the rocky road of disharmonious discord from day one? There are 5 easy tips for [...]

15 09, 2011

Delays in licensing approvals in India

By | 2016-10-10T17:05:59+00:00 September 15th, 2011|Categories: News|Tags: , , , |

Marketing licenses for biotechnological drugs as well as those used in clinical trials are being rejected by India’s apex pharmaceutical regulator, known as the DCGI, or Drugs Controller General of India. In the last year they have tightened the mechanism for approval on all fronts for therapeutic agents. Both domestic and multinational companies are facing much regulatory scrutiny and are often asked to make some changes in order to be [...]

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 [...]

2 09, 2011

India – CDSCO*: New Guidelines on Reporting Serious Adverse Events in India

By | 2016-10-10T16:22:05+00:00 September 2nd, 2011|Categories: News|

In May of this year the DCGI issued guidelines to report Serious Adverse Events in India (SAEs), the aim of these guidelines is to standardize and mainstream SAE reporting in this country. Conversely to the FDA, there is no 1571 when submitting an addendum or amendment to the DCGI and therefore, one of the first steps to mainstream SAE reporting was to set up a coversheet to be enclosed with [...]

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