nonclinical drug safety assessment
Tài liệu drug safety fda has begun efforts to enhance postmarket safety potx
Ngày tải lên: 23/02/2014, 21:20
Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology
... safety assessment strategies and guidelines, Rome, Italy) 38 Substantial equivalence is not a conclusion drawn from a safety assessment It is a process to identify differences that warrant safety assessments ... premarket safety assessment of GM foods and feeds provides a scientific basis for ensuring the safety of the food and generally eliminates the need for postmarket monitoring The premarket safety assessment ... not present new safety issues Hence the safety and nutritional assessment of these products can rely on COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY Vol 3, 2004 ILSI: Assessments of foods...
Ngày tải lên: 13/03/2014, 21:58
drug safety evaluation
... Techniques in Drug Safety Assessment 634 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation 691 Chapter 19 Safety Pharmacology 737 Chapter 20 Evaluation of Human Tolerance and Safety in ... Carcinogenicity Studies 297 Chapter 10 Safety Assessment of Inhalant Drugs 335 Chapter 11 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment 367 vii viii CONTENTS Chapter ... recent marketed drug withdrawals for safety (summarized in Table 1.1) and at rates of drug- related Liver=Kidney Damage QT internal prolongation= ventricular arrhythmias (deaths) Drug- drug interactions...
Ngày tải lên: 11/04/2014, 01:13
safety assessment of roundup readycorn event nk603
... feed and environmental safety assessments confirm the safety of this product The analyses included: 1) detailed molecular characterization of the introduced DNA; 2) safety assessments of the expressed ... proteins are indistinguishable with the antibody used in these assays Safety Assessment of CP4 EPSPS Proteins in Corn Event NK603 Safety assessments of the CP4 EPSPS proteins expressed in corn event ... human and animal health safety of corn event NK603 and the nutritional equivalence of corn event NK603 to conventional corn varieties Environmental Assessment Environmental assessment of plants...
Ngày tải lên: 01/07/2014, 18:01
Báo cáo y học: " Safety assessment of inhaled xylitol in mice and healthy volunteers" ppsx
... normal subjects We compared the safety and tolerability of aerosolized xylitol with normal saline, and carried out additional exposure studies using mice Methods Safety in normal mice All experiments ... doses of 12.5, 25 and 50 mg/ml Safety in normal volunteers The study was approved by the University of Iowa Institutional Review Board as well as the Food and Drug Administration Since this is ... 150 minutes Page of 10 (page number not for citation purposes) Respiratory Research 2004, 5:13 Safety in hypersensitive mice We repeated the saline and xylitol exposure protocol to more groups...
Ngày tải lên: 12/08/2014, 18:21
Báo cáo y học: "Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis" pot
... all clinical trials During infusion period Type of event Post-infusion period Drug related (n [%]) Not related (n [%]) Drug related (n [%]) Not related (n [%]) All ICH bleeding 12 (0.4) (0.1) (0.2) ... in which direct compression might be expected to control bleeding), could improve the safety profile of the drug Additionally, approved product labels recommend stopping the drotrecogin alfa (activated) ... Hempelmann G, Butler T, Martin E, Zwingelstein C, Percell S, Shu V, Leighton A, Creasey AA: Assessment of the safety of recombinant tissue factor pathway inhibitor in patients with severe sepsis: a...
Ngày tải lên: 12/08/2014, 19:22
safety assessment of sea dikes in vietnam a case study in namdinh province
... carry out an overall safety base on probabilistic assessment of the safety of Namdinh sea dikes o Finally, the conclusions and recommendations will be treated in chapter Safety Assessment of Sea ... dikes in Vietnam Deterministic assessment of the safety of Namdinh sea dikes by applying Vietnamese and Dutch codes Includes: Hydraulic related problems Safety Assessment of Sea Dikes In Vietnam ... aspects: - Deterministic assessment of safety of the sea dike system in Namdinh province by applying the sea dike Design Standards of Vietnam and the Netherlands The safety assessment will be done...
Ngày tải lên: 03/10/2014, 13:14
Uncertainty and imprecision in safety assessment of offshore structures
... crucial point for a reliable safety assessment of existing offshore structures, which is essentially the motivation for this thesis Among the various views of the safety assessment of an aging offshore ... probabilities 18 1.3 Safety Assessment of Offshore Structures 27 1.3.1 Reliability analysis 28 1.3.2 Robustness assessment ... of the available information regarding marine corrosion and marine growth effects through the safety assessment of offshore structures In view of an appropriate mathematical modeling in accordance...
Ngày tải lên: 10/09/2015, 08:39
Quality and safety assessment of sexual performance enhancement herbal medicines
... (CPM) (the final dosage forms) are classified as drugs and the Drug Administration law requires these drugs to be evaluated for safety and efficacy Drugs will have to be produced according to GMP ... drug developed for pre-menopausal woman with hypoactive sexual desire disorder (HSDD) The New Drug application for flibanserin was rejected by FDA Advisory Committee for Reproductive Health Drugs ... XW, Lee R, bloodworth BC, Koh HL 2009 Safety and quality assessment of 175 illegal sexual enhancement products seized in red-light districts in Singapore Drug Saf 32: 1141-1146 Häberli A, Girard...
Ngày tải lên: 13/10/2015, 15:55
Practical industrial safety, risk assessment and shutdown systems, elsevier (2003)
... functional safety makes a contribution to overall safety 8 Practical Industrial Safety, Risk Assessment and Shutdown Systems for Industry Overall Safety is seen as part of overall safety Protection ... Management of Functional Safety, F.S Assessment | Part 7: Overview of techniques and measures Part 1: Dev of overall safety requirements Part 1: Allocation of safety reqs to the E/E/PE safety- related systems ... hazards Overall safety requirements specification Safety requirements allocation To develop the overall safety requirements specification (in terms safety functions requirements and safety integrity...
Ngày tải lên: 02/01/2014, 09:47
Tài liệu Assessment of the AHRQ Patient Safety Initiative pptx
... of patient safety activities related to the initiative Assessment of contributions by AHRQ-funded patient safety projects to patient safety knowledge and patient safety practices Assessment of ... ULP USP VA project officer probabilistic risk assessment Patient Safety Indicator Patient Safety Improvement Corps patient safety organization Patient Safety Task Force Quality Improvement Organization ... to strengthen patient safety practices Assessment of dissemination of new knowledge to stakeholders in the field Assessment of progress in adoption of effective patient safety practices Product...
Ngày tải lên: 18/02/2014, 01:20
Assessment of the AHRQ Patient Safety Initiative docx
... Patient Safety Patient Safety Improvement Corps Patient Safety Indicator patient safety organizations patient safety and quality improvement Patient Safety and Quality Improvement Act Patient Safety ... documentation patient safety activities related to the initiative Assessment of contributions by AHRQ-funded patient safety projects to patient safety knowledge and patient safety practices Assessment of ... Safety Projects 32 Table 4.4 Patient Safety Actions Addressed by the AHRQ-Funded Patient Safety Projects 33 Table 4.5 Health Care Settings Addressed by the AHRQ-Funded Patient Safety...
Ngày tải lên: 15/03/2014, 22:20
EVENT SAFETY RISK ASSESSMENT AND EVENT MANAGEMENT PLAN pot
... and when? Notes EVENT SAFETY RISK ASSESSMENT (SMALL TO MEDIUM SIZED COMMUNITY EVENTS) RISK ASSESSMENT – IT’S A MUST The success of your event is measured in many ways and safety is one of them ... publication you should always refer to the latest laws EVENT SAFETY RISK ASSESSMENT - (SMALL TO MEDIUM SIZED COMMUNITY EVENTS) RISK ASSESSMENT Risk assessment is the process of estimating the potential ... and Safety issues - the organisers of the event should ensure that contractors employed to set up/take down stands, exhibits, marquees etc submit appropriate health and safety policies, risk assessments...
Ngày tải lên: 30/03/2014, 16:20
Báo cáo khoa học: "Safety margin in irradiation of colorectal liver metastases: assessment of the control dose of micrometastases" potx
... extent of a safety margin are not fully understood Surgical studies dedicated to this issue have demonstrated a lower rate of local tumor recurrences in patients resected with a safety Page of ... 10.1186/1748-717X-5-24 Cite this article as: Seidensticker et al., Safety margin in irradiation of colorectal liver metastases: assessment of the control dose of micrometastases Radiation Oncology ... differences between the groups were only found for distances ≤ mm as compared to > 15 mm for the assessments across readers (p = 0.0442) Stratification of the tumor recurrence from micrometastases...
Ngày tải lên: 09/08/2014, 08:23
Báo cáo y học: "Safety and anti-HIV assessments of natural vaginal cleansing products in an established topical microbicides in vitro testing algorith" ppsx
... countries foster the use of commercially purchased and chemically defined drug substances for HIV prevention and a success-by-design drug development strategy, the situation in low resource settings ... is unacceptable For microbicide safety evaluations, exposure time, mode of application, and microbicide formulation are key determinants In response to these safety concerns, several governmentand ... Recommendations for the nonclinical development of topical microbicides for prevention of HIV transmission: an update J Acquir Immune Defic Syndr 2004, 36:541-552 [http://www.fda.gov/Drugs/GuidanceComplianceRegulatory...
Ngày tải lên: 10/08/2014, 05:21
Báo cáo y học: " Phytol-based novel adjuvants in vaccine formulation: 1. assessment of safety and efficacy during stimulation of humoral and cell-mediated immune responses" doc
... Isotype Assessment of classes induced in response to immunizations Figure with ortho-phthalate-KLH conjugates in various adjuvants serum IgG antibodies and subclasses of phthalate-specific Assessment ... mice respectively In addition, this study also addressed the issue of safety relative to efficacy of phytolbased adjuvants Safety evaluation has been performed from the perspectives of toxicity, ... commonly used adjuvants Assessment of anti-phthalate and cross-reactive anti-DNA antibody responses in the presence of various adjuvants is thus a novel approach for evaluating the safety and effectiveness...
Ngày tải lên: 11/08/2014, 10:23
báo cáo khoa học: " Rapid assessment response (RAR) study: drug use and health risk - Pretoria, South Africa" ppsx
... http://www.harmreductionjournal.com/content/8/1/14 injecting equipment and/or drug- related unprotected sex, as was found in the rapid assessment of drug use and sexual HIV risk patterns among vulnerable drugusing populations in Cape Town, ... Stimson GV, Suresh Kumar M: Rapid assessment in the drugs field International Journal of drug policy 2000, , 11: 1-2, 1-11 Braam R, Verbraeck H, Trautmann F: Rapid assessment and response (RAR) on ... effective health services to reduce drug related harm [7] Injecting drug use is an increasing cause of HIV transmission, the number of countries in which injection of drugs has been reported has increased...
Ngày tải lên: 11/08/2014, 18:20
báo cáo khoa học: " Prevalence and correlates of HIV, syphilis, and hepatitis B and C infection and harm reduction program use among male injecting drug users in Kabul, Afghanistan: A cross-sectional assessment" ppsx
... [7,8] Since the 2006 study, drug use patterns and the number of drug users have changed, with the numbers of drug users, injectors, and those using heroin as their drug of choice increasing in ... links between drug use and HIV epidemics: an international perspective J Acquir Immune Defic Syndr 2010, 55(Suppl 1):S10-6 United Nations Office on Drugs and Crime (UNODC): Afghanistan Drug Use Survey ... Bayan S, Wardak SR, Strathdee SA: A qualitative assessment of injection drug use and harm reduction programmes in Kabul, Afghanistan: 2006-2007 Int J Drug Policy 2009, 20:111-20 21 Hope V, Kimber...
Ngày tải lên: 11/08/2014, 18:20
Báo cáo y học: "Drug monitoring in child and adolescent psychiatry for improved efficacy and safety of psychopharmacotherapy" pdf
... Increased drug metabolism Reduced storage of lipophilic drugs Faster urinary excretion Increased drug availability Increased drug availability both in peripheral organs and the brain Insufficient drug ... the therapy with psychotropic drugs in child and adolescents Finally, therapeutic drug monitoring (TDM), an appropriate tool for the improvement of dosing and drug safety, and the German-Austrian-Swiss ... same drugs, prescribing drugs "off label" can place the paediatric population at a direct risk of under- or overdosing and a delayed risk of longterm side effects The deficiencies of paediatric drug...
Ngày tải lên: 13/08/2014, 18:21