Phase I – BA / BE Studies in Special Patients
The objectives of Phase I studies include the estimation of safety and tolerability with the initial administration of an investigational new drug in the human body. Clinical studies in this Phase of development have non-therapeutic objectives and may be usually conducted in healthy volunteers only.
Drugs with significant potential toxicity (e.g. cytotoxic drugs for cancer or HIV patients; psychiatric drugs for CNS patients; etc.) are studied in the typical patient population for which the drug is intended to be used. This means that these patients would have to be studied only at hospital settings and not in a routine BA / BE study facility.
We at Consortium
Clinical Research, extend our technical expertise along with our strong relationships with the specialty hospital wings & Investigators in ensuring that the Pharmacokinetics & Pharmacodynamics data from these types of special patients are collected and collated for our Clients as per the Protocol and the statutory requirements.