Implications of Phase I Studies
Medical research and studies in India have been expanding in terms of medical experiments, studies and researches. In the recent past, eminent medical institutes and clinical research organization (CRO) have been deeply involved in conducting Phase I studies and other researches associated with it. This branch of medical study involves new treatment, cures, drug development and diagnosis. It looks in to the amount of drugs used on a patient.
Objective of Phase I Study
The main objective of clinical Phase I studies is to learn about the appropriate dosing schedule. In addition to that, it also analyses the manner in which a specific drug is consumed and the frequency at which it is given to the patient. In this process, clinical researchers and professionals concentrate on updating their knowledge about a drug and its toxic and other side effects.
Today leading CRO’s in India are involved in Phase I Studies that is supported by their huge experience in clinical trials . These medical institutes are equipped with innovative state-of-the-art medical architecture and have medical volunteers who assist in the studies. The main components of Phase I Study are:-
* First-in-human
* Single Ascending Dose studies
* Multiple Ascending Dose studies
* New Chemical Entities
* Dose Escalating studies
Apart from the services mentioned above, renowned clinical research organizations in India also comprise Phase I Studies in First –in-Man for the New Chemical Entities (NCE’s) and also the New Biological Entities (NBEs). Furthermore, there is a vast array of medical pharmacology studies that includes Drug inspection studies, Food Effect, Proof of Mechanism & Proof of Concept, TQTc studies, Pharmacokinetic/Pharmacodynamic studies and other allied explanatory studies for various biomarkers and Special Popular studies.
This apart, infrastructure too has an important role to play in Phase I Studies. Majority of CRO’s have standard bed units that are well managed by a team of trained medical technicians. The technicians have the required medical expertise and are equipped with other advanced and sophisticated medical devices. Furthermore, there are trained professionals and nursing staffs, having hands on experience in carrying out First-in-human and other clinical Pharmacology studies.
Renowned CRO’s in India have the experience in carrying out clinical trials, experiments and studies in special and patient populations. Their service covers Phase I to III studies for multiple pharmaceutical and biotechnology studies and help in ongoing clinical trials. Other than this, there are other services too that they offer, that includes Bio Studies, Biometrics , Medical Writing, Regulatory Compliance Services, Bioanalytical Research and many more. Furthermore, they have an outstanding track record for their services, client feedback and testimonials.
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