Objectives of Clinical Phase 1 Studies
The objective of medical science and technology has always been to come up with better and efficient modes of treatment to release human being from critical diseases. Over the past few years there have been tremendous changes and developments taking place in the medical landscape. Developments of new medical treatments and drug development methods have been on the rise keeping in mind the chronic ailments and other medical causes. In order to facilitate the process of clinical trials and researches, eminent clinical research organizations (CRO) conduct various medical studies and experiments in their clinical laboratories that are equipped with advanced medical equipments and apparatus. They help the medical technicians to arrive at results that are accurate within a short span of time.
One of the notable categories of medical studies include the Phase 1 Study that is aimed at studying certain medical conditions, the impact of drugs on the human blood samples and then arrives at justified conclusions. Eminent Indian CRO’s today, successfully conduct Phase 1 Studies and are supported by their huge experience in clinical trails. These CRO’s also offer healthy medical volunteers along with state-of-the art infrastructure. The core components of this kind of study include the following:
* First-in-human
* Single Ascending Dose studies
* Multiple Ascending Dose studies
* New Chemical Entities
* Dose Escalating studies
Renowned CRO’s in India provide specialized services for Phase 1 Studies for instance First in Man for the new chemical entities i.e. NCE’s and the new biologicalentities i.e. NBE’s. They also provide a host of clinical pharmacology studies that comprise the following:
* Proof of Mechanism and Proof of Concept
* Food Effect
* Drug interaction studies.
* Pharmacokinetic / Pharmacodynamic studies
* TQTc studies
Furthermore, they also specialize in explanatory services for numerous biomarkers and multiple special population studies. Other than this they also offer services such as medical writing, quality assurance, biometrics , Bioanalytical studies and many more.
This apart, infrastructure too has a huge role to play in Phase 1 Studies. Esteemed CRO’s offer fully equipped bed units that are aptly managed by a group of expert medical professionals having the desired experience. There are also the state-of-the-art clinical devices handled by expert medical technicians and nursing staff. These nursing staff has got hands on experience in First in human and other medical pharmacology studies that helps in conducting Phase 1 studies and trials.
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