Multiple Aspects of Phase I Studies
India records over a billion population count and is also known to be affected by various chronic ailments. Such factors offer a scope for global medical practitioners and healthcare professionals to consider the country as an essential destination for clinical studies and researches. India has already encountered a quick growth in the percentage of clinical trials over the past few years. This suggests that India has evolved as one of the most lucrative destinations for medical research.
As per a research report “Booming Clinical Trials Market in India”, the amount of clinical studies undertaken by global as well as domestic players has risen sharply. Some of them are eminent medical institutions and CRO’s that have resulted in the increase of strategic collaboration and service agreements over the past few years. Most CRO’s are highly focused in the market to establish strategic alliances with other CRO’s, pharmaceutical and biotech organizations, as well as technology providers. Furthermore, favorable government assistance and efficient regulatory mechanism offered by various healthcare providers find it worthwhile to have their trials in the Indian sub continent. This apart, with the accessibility of skilled manpower and proper medical architecture will help in increasing the number of clinical trials and other medical studies to 1900 by 2013.
Mulling on medical studies an essential section that deserves mention is the Phase i studies that numerous CRO’s specialize in. They provide state -of –the- art infrastructure along with healthy volunteer groups. Some of these studies include the following:-
First-in-human
Single Ascending Dose studies
Multiple Ascending Dose studies
New Chemical Entities
Dose Escalating studies
Apart from various clinical laboratory services CRO’s in India specializes in services for Phase I Studies that comprises First-in-Man for new chemical entities (NCEs) and new biological entities (NBEs). In addition to that, they also provide services for a wide range of clinical pharmacology studies that consists of Proof of Mechanism & Proof of Concept, Food Effect, Drug Interaction studies, TQTc studies, Pharmacokinetic / Pharmacodynamic studies, exploratory studies for numerous biomarkers as well as special population studies.
Clinical infrastructure plays an essential role in Phase I and other medical studies. The CRO’s offer a well managed team for such studies who have vast experience and are backed up by state-of-the-art medical devices, expert physicians and other well trained nursing staff having the expertise and knowledge to execute a host of Clinical Pharmacology studies.
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