Nithya J Gogtay

..There is an urgent need for the practitioners of the allopathic and non-allopathic systems to work together to optimise the risk-benefit profile of these medicines...

..We aimed to assess the challenges in defining who is a normal volunteer and the issues that affect volunteer recruitment and thus accrual...

..9-7.9%. They also constitute a significant economic burden. We thus aimed at determining the prevalence and the economic burden of ADRs presenting to Medical Emergency Department (ED) of a tertiary referral center in India..

..Warning letters (WLs) issued by the US FDA (United States Food and Drug Administration) mention the nature of violations by clinical investigators and institutional review boards (IRBS) and can help as training tools...

..Over and above this, sample size calculations must take into account all available data, funding, support facilities, and ethics of subjecting patients to research...

..An earlier pilot study suggested that 75 mg of bulaquine (BQ), of which PQ is a major metabolite, may be a useful alternate to PQ...

..Adverse event monitoring programs must also actively seek AHS reports to estimate its true incidence...

..05) in off-label use between patients with multiple system affection and those with single system affection and between those requiring artificial ventilatory support and those not requiring it...

..The potential of first-line aromatic anticonvulsants to cause AHS should be remembered in a patient who has developed AHS on exposure to lamotrigine. Timely recognition of this rare but potentially fatal drug reaction is important...

....

..The potential of lamotrigine to cause AHS should be remembered when this drug is used in subjects who have developed AHS on exposure to phenobarbital and other first-line antiepileptic agents...

..There therefore appears to be a need to review the current, gametocytocidal, primaquine-dosage schedule and to re-treat patients who remain gametocytaemic with higher doses of primaquine, as an important, transmission-blocking strategy...

....

....

..Inappropriate medication usage has been regarded as an important factor contributing to AEs in them. Beers criteria are a set of standard criteria for guiding drug prescription in elderly...

..CONCLUSIONS: Switch to a more expensive drug like mefloquine as a first-line option would be cost-effective when the moderate-severe chloroquine resistance exceeded 9%...

..This study investigates whether clinical malaria in hypoendemic regions exhibits a sex bias and whether this bias is age-dependent. We also consider the role of vector exposure in this bias...

..The present study evaluated the activity of CYP2C19 in normal, healthy Gujrati and Marwadi subjects by phenotyping (a western Indian population)...

..CYP2C9 and VKORC1 polymorphisms have been shown to affect warfarin dose requirement. However a large amount of the variation in warfarin dose remains unaccounted for...

....

..The combination was found to be significantly more effective, in terms of 28- or 42-day cure rates, and to be more cost-effective...

..To determine the extent and nature of off-label drug use in children admitted to a pediatric general ward in a tertiary health care centre..

..While the safety of the combination has been ascertained, the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up...

....

....

..The results of the study show that in India switching phenytoin brands could have significant implications and is not advisable once a patient is carefully titrated on one formulation...

..To achieve this aim, establishing in-hospital computerized event monitoring program in major hospitals and an effective national post- marketing drug surveillance network are the need of the hour...