Evidences of hepatoprotective and antioxidant effect of Citrullus colocynthis fruits in paracetamol induced hepatotoxicity.

The objective of present study was to explore the hepatoprotective and antioxidant profile of Citrullus colocynthis fruits. Hepatoprotective profile of methanolic extract of Citrullus colocynthis fruits (MECCF) was investigated on rats, which were made hepatotoxic using paracetamol. The antioxidant profile of MECCF was evaluated by conducting Catalase, Super oxide Dismutase, Lipid Peroxidation and Diphenyl Picryl Hydrazyl tests. During hepatoprotective investigation, the Paracetamol treated group II showed significant increase in total bilirubin (TB), serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT) and alkaline phosphatase (ALP) level. The results so obtained showed that pretreatment of rats with MECCF 300mg/kg p.o. decreases the elevated TB, SGOT, SGPT and ALP serum levels. Also, MECCF inhibitory profile was found comparable with toxicant group (Paracetamol 2g/kg, p.o.). The present study concludes that MECCF fruit possess significant hepatoprotective and antioxidant activity.

Phase zero trials: a novel approach in drug development process.

OBJECTIVE: The objective of this review is to explore the concept of phase 0, its contribution and also its practical guidance in drug development process. The process of drug development is protracted, complicated and requires lot of money. Phase 0 focuses on the aspect of microdosing, which determines the relation between PK & PD profile of drug; also selection of lead compound. Concept of phase 0 balances the planning of study scale between animal and human being, and creates a new way of defining phase I. Time is not too far when advance techniques and methods will be developed for the phase 0 studies to make it convenient and widely applicable in the design and development of majority of drugs. CONCLUSION: Although studies are yet to be done for phase 0 trial, it can be recognized that phase 0 trials would provide an opportunity to generate essential human PK and PD data much earlier in a drug development process, which could be a major advantage in design and decision making for further clinical development of an agent.