We conducted a comprehensive analysis of clinical pharmacology evaluations in initial submissions of 56 oncology new molecular entities approved by the US Food and Drug Administration between January 2011 and April 2017. Results from studies evaluating food effect, QTc prolongation, drug-drug interactions, renal and hepatic impairment effects, and dose optimization, as well as postmarketing req...

Article history: Received 11 November 2016 Accepted 11 November 2016 Available online 15 November 2016 drug studies but it is crucial to realise that gametocytaemia is a weak surrogate marker of mosquito infectivity. Gametocyte density has been shown to correlate withmosquito infectivity in untreated individuals in a non-linear relationship (Jeffery and Eyles, 1955) (Churcher et al., 2012). Pos...

The essential purpose of this paper is to consider in detail the knowledge of the prerequisites for drug studies in humans. In fact, the transition from the animal to man is always difficult, and very strict regulations have been established so that phase I trials (the first level of studies in man) can be performed in conditions ensuring the greatest safety for the individuals concerned.

Nearly every aspect of anesthesia care involves a strong working knowledge of the pharmacodynamics and pharmacokinetics of a vast number of drugs. Several times each year, anesthesia providers are challenged with the introduction of a drug new to the market. Most healthcare providers understand that before a new drug can be used to treat patients, it must be put through meticulous clinical tria...

promethazine hydrochloride, a 5-ht3 antagonist is a powerful antiemetic drug with an oral bioavailability of 25% due to extensive hepatic first pass metabolism and is extremely bitter in taste. to overcome the above draw backs, the present study was carried out to formulate and evaluate fast dissolving taste masked wafers of promethazine hydrochloride for sublingual administration. taste maskin...

Objective(s): A Box-Behnken design was used for evaluation of Eudragit coated diclofenac pellets. The purpose of this work was to optimize diclofenac pellets to improve the physicochemical properties using experimental design. Materials and Methods: Diclofenac was loaded onto the non-pareil beads using conventional coating pan. Film coating of pellets was done at the same pan. The effect of pla...