Use of Bayesian Statistics in Drug Development: Advantages and Challenges.

Use of Bayesian statistics in drug development: Advantages and challenges.

Int J Appl Basic Med Res. 2012 Jan; 2(1): 3-6
Gupta SK

MAINLY, TWO STATISTICAL METHODOLOGIES ARE APPLICABLE TO THE DESIGN AND ANALYSIS OF CLINICAL TRIALS: frequentist and Bayesian. Most traditional clinical trial designs are based on frequentist statistics. In frequentist statistics prior information is utilized formally only in the design of a clinical trial but not in the analysis of the data. On the other hand, Bayesian statistics provide a formal mathematical method for combining prior information with current information at the design stage, during the conduct of the trial, and at the analysis stage. It is easier to implement adaptive trial designs using Bayesian methods than frequentist methods. The Bayesian approach can also be applied for post-marketing surveillance purposes and in meta-analysis. The basic tenets of good trial design are same for both Bayesian and frequentist trials. It has been recommended that the type of analysis to be used (Bayesian or frequentist) should be chosen beforehand. Switching to an analysis method that produces a more favorable outcome after observing the data is not recommended. HubMed – drug


Colesevelam hydrochloride: A novel agent in patients with type 2 diabetes.

Int J Appl Basic Med Res. 2011 Jul; 1(2): 113-5
Sekhri K, Saha L

Hyperglycemia and hyperlipidemia are both risk factors for the development of various complications in patients with type 2 diabetes mellitus. Colesevelam hydrochloride is a novel agent that can improve both hypercholesterolemia and hyperglycemia in such patients. It is an orally administered bile acid sequestrant with high capacity for binding bile acids. This drug can offer potential new diabetes treatment along with other drugs. HubMed – drug


Cutaneous adverse drug reactions in a tertiary care teaching hospital: A North Indian perspective.

Int J Appl Basic Med Res. 2011 Jan; 1(1): 50-3
Nandha R, Gupta A, Hashmi A

Cutaneous manifestations of adverse drug reactions are a common occurrence and need to be differentiated from other causes of similar manifestations. Active search is essential for identification of these as patients may tend to downplay the causal association between drug use and the subsequent cutaneous manifestation.To study the incidence of Cutaneous Adverse Drug Reactions (CADRs) in a tertiary care teaching hospital in North India.A prospective, observational study was conducted over a period of 6 months; using self-reporting method for selection of cases. The CADRs were graded as definite, possible and probable.During the study period, 91 cases of CADRs were observed. Maximum incidence of CADRs was seen with antimicrobials (48.30%), followed by nonsteroidal anti-inflammatory drugs (21.90%). Maculopapular rash was the most common cutaneous manifestation of ADRs (42.85%).CADRs are a common occurrence and awareness about the same is essential for diagnosis and prevention. HubMed – drug


Bioenhancers from mother nature and their applicability in modern medicine.

Int J Appl Basic Med Res. 2011 Jan; 1(1): 5-10
Randhawa GK, Kullar JS, Rajkumar

Concept of bioenhancers or biopotentiators was first time reported in 1929 by Bose. A bioenhancer is an agent capable of enhancing bioavailability and efficacy of a drug with which it is co-administered, without any pharmacological activity of its own at therapeutic dose used. Development and consequent isolation of these molecules, such as piperine and quercetin, is considered as scientific breakthrough. A fixed drug combination (Risorine) of rifampicin, isoniazid, and piperine is the result of this research. It contains almost 60% less dose of rifampicin because of its increased bioavailability and it also prevents resistance. This concept is mentioned as yogvahi in ayurveda and was used to increase the effect of medicines by increasing oral bioavailability, decreasing adverse effects and to circumvent parenteral routes of drug administration. More such useful and economically viable drug combinations can be developed by integrating knowledge of time tested ayurveda with modern methods of research. This review is an account of these bioenhancers, available from the natural resources. HubMed – drug


Preliminary evaluations related to the ranges of hematological and biochemical variables in hospitalized patients with stroke.

Int J Prev Med. 2013 May; 4(Suppl 2): S347-52
Chitsaz A, Tolou-Ghamari Z, Ashtari F

According to the international reports, brain stroke is the main reason of death and disability. In ischemic stroke, early and precise classification of patients who may profit from conflicting finest therapeutic interference is necessary if enhanced effects in terms of survival are to be talented. Due to uncomplicated, easy performance, and inexpensive method the aim of this preliminary study was to investigate changes related to biochemical and hematological variables in patients with stroke.A cross-sectional study located at the neurology ward of the Ayatolah Kashani and Alzahra Hospitals’ (conducted to Isfahan Neurosciences Research Center) was carried out on fifty patients (females; n = 20 and males; n = 30) between April 1, 2012 and September 31, 2012. The data from subjects’ records were taken for analyzing variables. The statistical analysis of d-base was performed using (SPSS) for windows.Analysis of available data showed that with a mean of 182.4 mg/dl, blood sugar (BS) ranged from 75 to 300 mg/dl (n = 15/50). The changes in hemoglobin (Hgb) (mean 4.6 g/dl, n = 27/50), platelet (mean 210, 653/mm(3), n = 26/50) and lymphocyte (Lymph) (mean 37, n = 26/50) seems to be significant. The mean age of females was 76 years (ranged 46-93 years). The mean age of males was 70 years (ranged 31-90 years). Information related to previous drug history was available only in 24 patients. In 5 out of 22 cases ischemic heart disease (IHD) were positive. In 8 out of 29 cases, diabetes mellitus was positive. In 5 out of 28 cases, hypertension (HTN) was positive. In the four patients both IHD and HTN were positive.Any considerable alter in patients’ biochemical and hematological figures (BS, Hgb, Plt and Lymph) may necessitate further attention related to inter- and intra-individual variability in clinical supervision and drug’s assortment. Therefore, success in treatment could be achieved by the close management of clinical, biochemical, hematological, and pharmacological manifestation. To reduce disability, mortality, and morbidity in Iranian stroke population further clinical studies are needed to correlate drugs and laboratory markers to associated clinical events in order. HubMed – drug