MICRODOSING: A NEW STRATEGY FOR DRUG DEVELOPMENT PROCESSAbstract
New drugs are a great need for clinical conditions but unfortunately development costs are rising and number of drugs receiving marketing approval has fallen. Microdosing is a new experimental approach that offers a faster and potentially less expensive approach for obtaining human in vivo pharmacokinetic (PK) data in early stages of drug development. The concept of microdosing involves the use of extremely low non-pharmacologically active doses of drug candidates to define their PK profile in human subjects, using highly sensitive analytical techniques such as Accelerator mass spectrometry (AMS), Positron emission tomography (PET) and Liquid chromatography-mass spectrometry-mass spectrometry (LC/MS/MS). In this review we have discussed various aspects of microdosing such as regulatory requirements, methodology, validation, experimental proofs and future aspects. In conclusion, progress on three fronts, namely analytical, regulatory and understanding the role of PK in drug development has bought pharmaceutical industry to a position where microdosing can be considered as a possible first step in clinical investigations and eventually all first in human studies will commence with a phase 0 study.
Pradnya Shinde*, Priti Patil , Manish Mandhare Yadunath Joshi , Leena Patil and Vilasrao Kadam
Department of Pharmacology, Bharati Vidyapeeth’s College of Pharmacy, CBD Belapur, Navi Mumbai-400614, Maharashtra, India
15 April, 2011
07 May, 2011
18 June, 2011
01 July, 2011