Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 1, Issue 3, 2014

Missing data due to dropout of patients in randomized clinical trials may be potential sources of bias in the efficacy evaluation of investigational drugs. The biases may be severe when the presence of missing data is substantial. Over the last two decades, extensive research works on dealing with missing data in clinical trials were conducted by both the academicians and pharmaceutical industry statisticians. Majority of the re Read More

Fluoride use as a chemotherapeutic agent for caries prevention has been well researched and documented. The recommendations for the use of fluoride have evolved through the years as a result of many factors. The change in the prevalence of caries and the advent of different fluoride formulations along with the desire to maximize the benefits and minimize the side effects lead many authorities to set guidelines for the Read More

Introduction: Limited data exist about the educational value of students performing a case based discussion (CbD) to a group of their peers. Aim: To evaluate the use of CbDs in a group format as an alternative to one on one CbDs. Methods: Foundation year one (FY1) doctors were invited to present a case that they had been involved in the care of to a group of their peers. The format would involve discussing the case and rel Read More

Over the last 30 years – there is enormous expansion of pharmaceutical research and clinical trials in the quest for new and effective drugs [1]. Many advances are taking place in the area of clinical trials. Thousands of compounds undergo extensive clinical testing for every new chemical entity (NCE) that receives marketing approval [2]. Clinical trials are the backbone of human therapeutic development process and requir Read More

Pricing is always important, because it facilitates growing of sales, and finally business. There is nothing like a magical pricing strategy. Nevertheless, we can get more money by actually adding some strategy flavor to our pricing. Pricing in the case of pharmaceuticals is unique, since while framing a strategy for it, the industry, the health authorities, pricing authorities, reimbursement authorities, physicians, insur Read More

Present day the biggest challenge faced by the pharmaceutical manufacturers is experiencing inspectional Food and Drug administration (FDA) 483’s, warning letters, import alerts and notice of violations from the regulatory authorities. The USFDA’s inspectional outcome has uncovered the retesting of drug ingredients that had failed quality testing, failure to establish corrective and preventive action following an investigatio Read More

Biobetters are new biological entities, that are related to approved biologics by target or action, but they are intentionally altered to improve disposition, safety, efficacy, or manufacturing attributes. Due to the growing need for lower cost better versions of biological medicines, the markets for biobetters are rising. Regulatory authorities of many countries have precise technical standards and legal pathway for appr Read More

We report two cases of one previously healthy child and another known to have G6PD deficiency, who presented with desaturation despite their stable clinical appearance, which later was attributed to methemoglobinemia (MetHb) that was precipitated by fava beans ingestion. When hemolytic crisis occurs, certain G6PD deficient patients might develop cyanosis and show evidence of concurrent methemoglobinemia. I Read More