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Therapeutic Areas (therapeutic + area)
Selected AbstractsApplicability and safety of recombinant activated factor VII to control non-haemophilic haemorrhage: investigational experience in 265 childrenHAEMOPHILIA, Issue 4 2008M. HERBERTSON Summary., Experience of recombinant activated factor VII (rFVIIa, NovoSeven®; Novo Nordisk A/S, Bagsvaerd, Denmark) to control haemorrhage in non-haemophilic children is limited. The object of this study was to examine the applicability and safety of rFVIIa amongst a group of non-haemophilic paediatric subjects. Details of all non-haemophilic children ,16 years receiving rFVIIa whose data were recorded in the investigational, internet-based registry, haemostasis.com were analysed. A total of 265 children (mean age 7.7 years) were treated with rFVIIa; the median dose administered was 78.4 ,g kg,1 body weight (range 9.0,393.4) and the median total dose received 100.0 ,g kg,1 body weight (range 10.9,1341.2). Therapeutic areas included surgery (34.5%), coagulopathy (including thrombocytopenia; 29.0%), spontaneous bleeding (17.2%), trauma (8.4%) and intracranial haemorrhage (4.5%). Two patients experienced thromboembolic events following administration of rFVIIa. Thirty-nine patients died on account of haemorrhage or complications relating to their underlying condition; neither the thromboembolic events nor the deaths were related to rFVIIa administration. Bleeding stopped in 118/237 (49.8%), markedly decreased in 54/237 (22.8%), decreased in 51/237 (21.5%), remained unchanged in 13/237 (5.5%) and increased in 1/237 (0.4%) patients. These results suggest that rFVIIa is safe and widely applicable in children to control non-haemophilic haemorrhage. [source] Statistical Tests Based on New Composite Hypotheses in Clinical Trials Reflecting the Relative Clinical Importance of Multiple Endpoints QuantitativelyBIOMETRICAL JOURNAL, Issue 5 2009Masako Nishikawa Abstract In clinical trials, several endpoints (EPs) are often evaluated to compare treatments in some therapeutic area. Suppose that there are two EPs in a clinical trial. We propose a new set of composite hypotheses for continuous variables, taking the relative clinical importance of the EPs into account. The main hypotheses were formulated to show that a treatment is so superior to the control treatment, which is not necessarily a placebo, in one EP, that the possible non-inferiority of the treatment by at most a certain value in the other EP can be compensated sufficiently, taking the clinical point of view into account. The maximum non-inferiority margin of one EP might not be a biologically unimportant difference in exchange for much superiority of the other EP. This formulation leads to a new composite EP and a very simple test statistic. The intersection-union principle was employed to derive the proposed test. [source] Feasibility study of multicentre comparison of NHS hospital pharmacy computer dataBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 1 2000Pauline Debra Walker Aims This study aims to determine the feasibility of collecting, collating and analysing drug expenditure data from a sample of acute hospitals in England. Methods The hospital pharmacy computer system was used to report on drug expenditure from 16 hospitals throughout England for a 2 year period. These data were analysed as a whole and hospital episode statistics were correlated to hospital drug costs. Results Hospital outpatient costs were found to be approximately one third of hospital inpatient costs. Cardiovascular drugs accounted for the greatest increase in expenditure for both inpatients and outpatients (25%). The most expensive therapeutic area of drug use across all sites was anti-infectives. The average daily number of occupied beds explained 55% of the variation in inpatient expenditure and the number of outpatient (including Accident and Emergency) attendances explained 60% of the outpatient drug expenditure. Conclusions This project has confirmed the feasibility of collecting, collating and analysing hospital drug expenditure and identified some interesting patterns and trends in hospital drug use. Hospital activity is reflected in hospital drug costs. [source] Extemporaneous product use in paediatric patients: a systematic reviewINTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 1 2008Ms Jennifer A Giam pharmacist, postgraduate student Objective To identify the relative extent of extemporaneous product use reported in the paediatric population and the implications for pharmacy practice. Method A systematic literature review was undertaken to identify the prevalence of extemporaneous product use in paediatric patients including those studies examining both ,off-label' and unlicensed medicine use from which extemporaneous products were separately identified and compared to licensed drug use. Key findings Twenty studies were identified and evaluated in which extemporaneous products prepared by a pharmacy or licensed manufacturer could be identified. Although prescribing of unlicensed drugs and licensed drugs used ,off-label' occurs more frequently in younger children and for more serious conditions, the use of extemporaneous products is consistent across all age groups and therapeutic areas. Studies using pharmacy dispensing records identified details of extemporaneous products more accurately than studies using prescribing records. Despite efforts to improve the availability of suitable licensed medicine products for children, extemporaneously prepared products are still needed to ensure that optimal drug therapy is available to children in accurate and effective doses and dosage forms. Conclusions Paediatric patients have a continuing need for extemporaneously prepared medicines when suitable dose forms are unavailable from manufacturers. Pharmacists require access to stability, compatibility and formulation information, as well as appropriate training to ensure patients are supplied with high-quality, safe and effective preparations. [source] Supplementary prescribing by community and primary care pharmacists: an analysis of PACT data, 2004,2006JOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 1 2008L. Guillaume BA MSc PhD Summary Background and objective:, Pharmacist prescribing is a relatively new intiative in the extension of prescribing responsibilities to non-medical healthcare professionals. Pharmacist supplementary prescribing was introduced in 2003 and allowed prescribing in accordance with a clinical management plan agreed with a medical practitioner and patient to improve patient access to medicines and better utilize the skills of healthcare professionals. The objective of this research was to examine the volume, cost and trends in pharmacist prescribing in community and primary care using Prescription Analysis and Cost (PACT) data and to suggest possible reasons for the trends. Methods:, Using PACT data at national, chapter and subchapter level for 2004,2006 the volume, costs and trends for pharmacist prescribing were obtained. Supplemental data and statistical analysis from other sources, relating to prescribing of individual drugs, were also utilized. Results:, The total number of items prescribed by pharmacists in community and primary care increased from 2706 in 2004 to 31 052 in 2006. In 2006, pharmacist prescribing represented only 0·004% of all prescribing in the community and primary care setting. Cardiovascular medicines were the most frequently prescribed therapeutic class followed by central nervous system, respiratory, endocrine and gastrointestinal medicines. Conclusion:, Pharmacist prescribing is increasing but represents an extremely small proportion of primary care prescribing. PACT data between 2004 and 2006 reflects pharmacist supplementary prescribing alone and has been in the anticipated therapeutic areas of drugs which treat chronic conditions such as hypertension. [source] Inosine monophosphate dehydrogenase (IMPDH) as a target in drug discoveryMEDICINAL RESEARCH REVIEWS, Issue 2 2008Qingning Shu Abstract Inosine monophosphate dehydrogenase (IMPDH) is a key enzyme of de novo purine nucleotide biosynthesis and is viewed as an important target in the quest for discovery of drugs in the antiviral, antibacterial and anticancer therapeutic areas. This review focuses on the medicinal chemistry, drug discovery and chemical biology of IMPDH. Examples of IMP and cofactor site-directed inhibitors, allosteric inhibitors and isoform-selective inhibitors are presented. Comparison of IMPDHs from different organisms is also made to facilitate the design of species-selective IMPDH inhibitors for drug discovery. Special emphasis in the review is placed on IMPDH from Mycobacterium tuberculosis. © 2007 Wiley Periodicals, Inc. Med Res Rev, 28, No. 2, 219,232, 2008 [source] Prescriber 1990,2010: key developments in drug treatmentPRESCRIBER, Issue 9 2010FBPharmacolS, Gordon McInnes BSc Our editorial consultants highlight the significant advances made in their therapeutic areas over the past 20 years. Here we look at developments in CVS and respiratory medicine and diabetes. Copyright © 2010 Wiley Interface Ltd [source] A Nonsurgical Technique for Blood Access in Extracorporeal Affinity Adsorption of Antibodies in RatsARTIFICIAL ORGANS, Issue 4 2007Linda Mårtensson Abstract:, Monoclonal antibodies for targeting cytotoxic conjugates to tumor cells are currently being evaluated together with extracorporeal affinity adsorption. The aim of the adsorption was to reduce undesired side effects in normal organs and to increase the tumor-to-normal tissue ratios. This technique is also applicable to several other therapeutic areas such as immune-mediated disorders, that is, autoimmunity, allergy, and transplantation rejection. We describe an improved technique for extracorporeal affinity adsorption of radiolabeled biotinylated antibodies in rats. Blood access is established through the tail artery and tail vein, without surgical insertion of permanent catheters. This technique is simple, does not require surgery, and causes only minimal stress to the animals. In addition, experiments can be carried out on several animals simultaneously. This new technique is of considerable benefit for studying extracorporeal affinity adsorption in rats, as experiments can be carried out with negligible anatomical and physiological interventions, compared to previously used techniques. [source] Baculovirus P35 protein: An overview of its applications across multiple therapeutic and biotechnological arenasBIOTECHNOLOGY PROGRESS, Issue 2 2010Sudhir Sahdev Abstract Baculovirus immediate early P35 protein is well known for its anti-apoptotic as well as anti-oxidant properties. Mechanism of action of P35 involves inhibition of a vast range of initiator to executioner class of caspases. In addition, P35's role in inhibiting oxidant-induced mitochondrial damage, primarily in the apoptotic pathway, has also been extensively investigated. Elucidation of P35's functions during regulation of programmed cell death (PCD) has led to a renewed focus on exploiting this basic knowledge for clinical and other related applications. This review outlines specific biochemical and genetic pathways where P35 intervenes and regulates rate-limiting steps in the apoptotic signaling cascade. Research efforts are underway to utilize P35 as an agent in regulating apoptosis and under certain circumstances, also explore the therapeutic potential of its anti-oxidant features. One of the major outcomes of recent studies include significantly improved effectiveness of cytochrome P450 directed enzyme pro-drug delivery tools when used in conjunction with P35, which may help in alleviating drug resistance in tumor cells and simultaneously prolonging the cytotoxic effects of anti-cancer drugs. Moreover, applied research carried out recently in the fields of diabetes, ischemia-induced neuronal cell death, experimental autoimmune encephalomyelitis (EAE), multiple sclerosis (MS), inflammatory arthritis, cardiovascular and ocular disorders illustrate P35's utilization across diverse therapeutic areas and will certainly make it an attractive biomolecule for the discovery research. © 2009 American Institute of Chemical Engineers Biotechnol. Prog., 2010 [source] Advances in histamine pharmacology reveal new drug targetsBRITISH JOURNAL OF PHARMACOLOGY, Issue 1 2009Paul L Chazot This Themed Issue consists of three reviews and 11 original articles authored by internationally respected industrial and academic pharmacologists from across three continents. It derives from the highly successful symposium on ,The H3 and H4 histamine receptors: the antihistamines for the 21st century', which took place at EPHAR 2008 in Manchester University, and encompasses new roles, new compounds and exciting new therapeutic areas for histamine. [source] | ||||||||||