Phase I Study & Drug Developmnet Process
A decade back could we have imagined that cancer could be treated and healed completely? Could we have imagined that there can other modes of treating cancer than chemotherapy and other heavy medications? The medical landscape has evolved manifold and has successfully introduced innovative diseases to some of life’s chronic diseases. Thanks to the latest scientific development and state-of-the-art medical infrastructure that has facilitated the diagnosis and treatment procedures. This apart, another crucial factor that has impacted the phenomenal expansion of medical treatment are clinical trials and important medical studies.
Medical studies are generally conducted by medical professionals and aspiring medical students on some of the chronic ailments to which there is no advanced cure. These medical studies are carried on in the form of a phased methodology with the help of necessary guidelines and with the help of all the required devices. Furthermore, these studies help to come up with new treatment and drug development process. To name one such branch of medical studies that has contributed immensely in treating diseases and ailments is the Phase I Study.
Today there are eminent clinical research organizations (CRO) in India that have been successful in carrying out Phase I studies along with their vast experience in clinical trials. These CRO’s provide the medical technicians with state-of-the-art architecture to conduct Phase I studies to the healthy volunteers. Some of the comprise of:
* First-in-human
* Single Ascending Dose studies
* Multiple Ascending Dose studies
* New Chemical Entities
* Dose Escalating studies
Renowned CRO’s in India provides specialized services for Phase I Studies, for instance First-in-Man for new chemical entities and new biological entities. It also offers a wide range of service portfolio for a wide range of clinical pharmacology studies that includes Proof of Mechanism & Proof of Concept, Food Effects, Drug Interaction studies, TQTc studies, Pharmacokinetic / Pharmacodynamic studies and other explanatory studies for multiple biomarkers and other Special Population studies.
Apart from the service portfolio, clinical infrastructure too has a huge role play in carrying out Phase I studies. These studies are managed by a group of experienced professionals having expertise on the field and works in close association will highly trained nursing staff. The nursing staff further has the medical know-how in conducting First-in-human and other clinical pharmacology studies. Eminent CRO’s in India along with Phase I Studies also specialize in other medical verticals such as Biometrics, Medical Writing, Regulatory Services, Quality Assurance and Phase II – IV trials.
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