Regulatory

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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 [...]

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 [...]

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 [...]