• Bioanalytical Method Validation: A Quality Assurance Auditor View Point

      In the development of medicinal products, bioanalytical methods are used in clinical and non-clinical pharmacokinetic studies to evaluate the efficacy and safety of drugs and their metabolites. Drug concentrations determined in biological samples are used for the assessment of characteristics such as in vivo pharmacokinetics (adsorption, distribution, metabolism, and excretion), bioavailability, bioequivalence, and drug-drug interaction. Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to give confidence in the results generated. It is the process used to establish that a quantitative analytical method is suitable for biomedical applications. Any method developed for the analysis of analytes in biological fluids must yield consistent results despite the variations in conditions during the course of a project. An ideal bioanalytical method should include all of the probable effects that are going to occur during the routine analysis of study samples. The present manuscript focuses on the consistent evaluation of the key bioanalytical validation parameters is discussed accuracy, precision, sensitivity, selectivity, limits ofquantification, range, linearity, ruggedness, robustness, and stability. Some of the proposals were made to the validation procedure to encounter the possible situations in the routine study sample analysis. An attempt has been made to understand and explain the bioanalytical method validation for chromatographic assays from the quality assurance auditor viewpoint. A good understanding of the background and principles of the bioanalytical method validation will help the quality assurance personnel to perform their duties in a most effective and focused manner. Download
    • Biological Activity of Pyrimidine Derivatives

      Anti-inflammatory efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) has been related to their properties as inhibitors of cyclooxygenase (COX)-mediated prostaglandin (PG) synthesis. However, recent studies have suggested that variations of the in vivo anti-inflammatory actions among different NSAIDs could not be solely explained by COX inhibition. Here, we have analyzed the effects on T cell activation of novel pyrazole derivatives. Pyrazoles represent a most active classes of compounds possessing a wide spectrum of biological activities. A systematic investigation of this class of heterocyclic lead revealed that pyrazole containing pharmacoactive agents play important role in medicinal chemistry. The prevalence of pyrazole cores in biologically active molecules has stimulated the need for elegant and efficient ways to make these heterocyclic lead. Pyrazole derivatives have a long history of application in agrochemicals and pharmaceutical industry as herbicides and active pharmaceuticals. Download
    • Biomarkers In Alcoholic Liver Disease

      Extreme alcohol ingesting is a major health problem in the universal leading to both severe morbidity and mortality. Prolonged and undue alcohol ingestion is one of the major causes of Liver diseases. Alcohol is considered as a direct hepatotoxin. Progressive firosis and cirrhosis, clinically presenting as end-stage liver disease are common outcomes in alcoholic Liver disease patients. The aim of this study is to identify potential novel biomarkers for progression of cirrhosis to end-stage liver cirrhosis. The different subjects were evaluated based in the age group. Blood samples were analysed for the analysis of different enzymatic levels. The urea, creatinine, albumin, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) are observed for the any rise or decline in it. The alcohol is responsible for abnormal haematological, renal and liver chemistries. Download
    • Beta Cell Regeneration and Recent Targets for Beta Cell Regeneration

      Diabetes mellitus is a chronic disorder characterized by high levels of sugar (glucose) in the blood. High amount of glucose in blood e.g: after a meal(carbohydrates, proteins,and fats), triggers the release of the insulin hormone from beta cells of the pancreas. Human pancreas is composed of an exocrine and an endocrine part, containing the islets of Langerhans(group of cells), which play a role in maintaining the appropriate level of sugars, proteins, and lipids.The agents that may induce formation of new b cells in humans includes the following:Gastrin and epidermal growth factor,Incretins, especially glucagon-like peptide 1 (GLP-1) and dipeptidyl peptidase-4 (DPP IV) antagonists,Islet neogenesis associated protein (INGAP) and its human equivalent, human proislet peptide (HIP). Download
    • Biological Overview on Azrines

      The azrines moiety is an important and showed some important biological activities. Recently, much attention has been focused on azrines derivatives for their scarcity of their pharmacological activities. Various substituted azrines derivatives were also reported to show antibacterial and cytotoxic properties. The combination of two or more heterocyclic and non-heterocyclic systems enhances or other substitution affect their biological profile than parent nuclei. We considered some compounds bearing azrines in their molecular framework. Download