The Ahmedabad based leading clinical research organisation (CRO), Veeda CR has recently opened its new clinical pharmacology unit (CPU) at Muljibhai Patel Urological Hospital (MPUH), Nadiad, Gujarat. The company will conduct phase I /II clinical studies in renal impaired patients at the unit. The company has not disclosed the financial term.
Studies involving renal impaired patients are particularly important for newly discovered drugs for which the way in which the body handles the drug is not known.
In a telephonic interaction with Pharmabiz, Dr Kiran Marthak, director said, "Conducting phase I studies on renal impaired patients is highly important as many drugs are excreted by the body via the kidneys and a knowledge of the influence of kidney function on drug metabolism is essential to drug development. Veeda clinical research is very proud to become the first ever CRO to establish a specialized renal CPU in India".
The company will also employ this unit for carrying out clinical trials related to urology like Ca prostate and Ca bladder which may necessitate admission in the ward which is in the hospital and immediately adjacent to the intensive care unit. The unit has six fully monitored beds and all the supporting facilities necessary for the safe conduct of clinical trials. Veeda will have access to the experienced manpower of the hospital as well as the facilities available like kidney dialysis machines, pathology laboratory, X-rays and CT scan.
At present it is conducting BA/BE studies of about 40 molecules at different stages of completion. So far company have conducted over 100 studies for US FDA of which 9 have been approved 3 were inspected by them. So far the company has conducted 483 studies. Whereas, about 11 phase I studies are at different stages of completion which are a mix of single ascending dose, multiple ascending dose, formulation effect, food effect, drug interaction and glucose clamping, of these majority are for new chemical entities.