Conclusion

There is an increased awareness both by the regulatory authorities and by drug sponsors on the importance of the elucidation of the potential for drug interactions of a new molecular entity. Establishing the drug interaction profiles of a new drug and providing proper information on dosing recommendations when certain drugs are given together is an important risk management tool and will go a long way in avoiding unwanted adverse events.

A well-designed program that takes into account the available in vitro technologies, the right in vivo studies, the appropriate model compounds and a population screen during the phase III trials will not only provide the necessary information that is required by regulatory agencies but will also provide guidance to the prescriber and patient on the appropriate dosing recommendations when multiple drugs are co-administered [102].

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