Phase I – BA / BE Studies in Special Patients
The objectives of Phase I studies include the estimation of safety and tolerability of an Investigational New Drug (IND) in the human body during the initial administration. 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 in a hospital setting and not in a routine BA / BE study facility.
We at Consortium Clinical Research, extend our technical expertise along with our network of specialty hospital wings & Investigators in ensuring that the Pharmacokinetic & Pharmacodynamic data from these types of special patients are collected and collated for our clients as per the Protocol and the statutory requirements.