Medical Facts about Phase 1 Studies
It is the expanding of the Indian economy during the early 20th century that resulted in an era of unprecedented industrial growth. In the recent times, we see that there have been great opportunities taking place within the global and domestic healthcare sector and have attracted the attention of Indian industries. The Indian healthcare system has made numerous important achievements in the past fifty years in terms of infant mortality, life expectancy, rate and success in dealing with multiple dangerous ailments. Apart from innovative drug developments, scientific medical researches, medical trials and scientific studies have made this possible.
According to Cygnus, India’s medical education market that also includes dental treatment, in 2009-2010 was Rs.21 billion. This has expanded by a CGAR of approximately 10 percent over the last three years. Cygnus also estimates that Indian medical education market will expand at a CGAR rate of 18 percent by the year 2012-2013 that would go up to Rs.35 billion. India in order to attain a 1:1,000 doctor-patient ratio and 1:7,500 dentist-to-population ratios requires approximately 600,000 doctors, 200,000 dental surgeons and one million nurses as recommended by the World Health Organization (WHO), India needs at least. This apart, in order to be able to deliver the latest treatment innovative medical studies, such as Phase I Studies needs to be facilitated.
Eminent clinical research organizations (CRO) in India today are associated with Phase 1 Studies are supported by huge experience in clinical trials. They have state-of-the-art medical infrastructure to carry on these studies along with efficient volunteers. They comprise the following:-
* First-in-human
* Single Ascending Dose studies
* Multiple Ascending Dose studies
* New Chemical Entities
* Dose Escalating studies
Infrastructure plays an essential part in Phase I studies. Most CRO’s have well developed bed units that are efficiently managed by a group of medical professionals. They also have access to other state of the art medical architecture and innovative equipments along with expert physicians and nursing staff, having the know how in First in Human and Clinical Pharmacology studies.
CRO’s provide specialized services for Phase I Studies such as First-in-Man for new chemical entities (NCEs) and new biological entities (NBEs). This apart they, also provide a wide range of clinical pharmacology studies that includes Food Effect, Proof of Mechanism & Proof of Concept, Drug Interaction studies, Pharmacokinetic / Pharmacodynamic studies, TQTc studies, exploratory studies for various biomarkers and various Special Population studies
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