Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

This Health Technology Assessment was commissioned by the "National system for the introduction of new health technologies within the specialist health service". The aim of this report was to assess the effect and cost-effectiveness of the disease modifying medicines used in Norway for patients with relapsing remitting multiple sclerosis (dimethyl fumarate, teriflunomide, interferon beta, peg-interferon, glatiramer acetate, natalizumab, fingolimod, and alemtuzumab). The key results are:1. We identified 37 randomised clinical trials. The quality of the available evidence ranged from very low to high.2. Alemtuzumab 12 mg had the best effect on annual relapse (for medicines we had evidence of high quality). Dimethyl fumarate 240 mg twice daily and fingolimod oral 0.5 mg were the most effective against disability progression (for medicines we had evidence of high quality).3. Our results indicated that interferon beta-1a 44 mcg and peg-interferon beta-1a were associated with more withdrawal due to adverse events than placebo. The examined treatments had no effect on mortality compared to placebo.4. Our health economic analysis, examining all multiple sclerosis treatment alternatives, indicated that alemtuzumab was more effective (in terms of quality-adjusted life-years (QALY)) and less costly than the other treatment alternatives. We did several scenario analyses and the cost-effectiveness results were robust to variations in the model assumptions.5. The results of a scenario analysis that excluded alemtuzumab (the dominant strategy), showed that three treatment alternatives (interferon beta-1b (Extavia), peg-interferon beta-1a and natalizumab) could be cost-effective depending on the willingness-to-pay (WTP) per QALY. Assuming a WTP below NOK 1,000,000, interferon beta-1b (Extavia) was 40% likely to be the most cost-effective treatment, followed by peg-interferon beta-1a (30% likely).6. The results of our model analysis showed that there is some degree of uncertainty regarding the input parameters. More research on efficacy and epidemiological data would have the greatest impact on reducing decision uncertainty.7. Our budget impact analysis based on the results of our cost-effectiveness analysis, the drugs' adverse events profile, and current clinical practice showed that there is a substantial potential for cost saving.

Cost effectiveness. --- Drug Evaluation, Preclinical.

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Drug development --- Drug development. --- Development of drugs --- Drugs --- New drug development --- Development --- Biological Assay --- Drug Evaluation, Preclinical --- Technology, Pharmaceutical --- instrumentation. --- methods. --- Pharmacology --- Pharmacy --- Pharmacology. Therapy

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Nutritionary hygiene. Diet --- Toxicology --- -Genotoxicity --- Genotoxicology --- Chemical mutagenesis --- Drug screening --- Toxicity --- -toxicity. --- Genetic toxicology --- Drug Evaluation, Preclinical --- Environmental Pollutants --- Mutagens --- Congresses --- methods --- toxicity --- Environmental pollutants --- Methods --- Congresses. --- Metals. --- Genetic toxicology - Congresses --- Mutagens - Toxicity - Congresses --- Drug screening - Methods - Congresses --- Environmental pollutants - Toxicity - Congresses --- Proteins

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy.

Drug abuse. --- Drugs. --- Psychopharmacology. --- Drug Evaluation, Preclinical --- Models, Animal --- Substance-Related Disorders --- Investigative Techniques --- Mental Disorders --- Drug Discovery --- Diseases --- Evaluation Studies as Topic --- Psychiatry and Psychology --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Substance Abuse --- Social Welfare & Social Work --- Social Sciences --- Drugs --- Opioids --- Overdose. --- Opium-like agents --- Analgesics --- Narcotics --- Opium --- Drug overdose --- Overdosage of drugs --- Overdose of drugs --- Poisoning --- Medication errors --- Drug use --- Substance abuse --- Overdosage --- Dosage

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Outside back cover : "Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, only a fraction have sufficient ADME (absorption, distribution, metabolism, elimination) properties, and acceptable toxicology properties, to become a drug product that will successfully complete human Phase I clinical trials. Drug-Like Properties: Concepts, Structure Design and Methods from ADME to Toxicity Optimization, Second Edition, provides scientists and students the background and tools to understand, discover, and develop optimal clinical candidates. This valuable resource explores physiochemical properties, including solubility and permeability, before exploring how compounds are absorbed, distributed, and metabolized safely and stably. Review chapters provide context and underscore the importance of key concepts such as pharmacokinetics, toxicity, the blood-brain barrier, diagnosing drug limitations, prodrugs, and formulation. Building on those foundations, this thoroughly updated revision covers a wide variety of current methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties for process and product improvement. From conducting key assays for interpretation and structural analysis, the reader learns to implement modification methods and improve each ADME property. Through valuable case studies, structure-property relationship descriptions, and structure modification strategies, Drug-Like Properties, Second Edition, offers tools and methods for ADME/Tox scientists through all aspects of drug research, discovery, design, development, and optimization.Provides a comprehensive and valuable working handbook for scientists and students in medicinal chemistry. Includes expanded coverage of pharmacokinetics fundamentals and effects. Contains updates throughout, including the authors’ recent work in the importance of solubility in drug development; new and currently used property methods, with a reduction of seldom-used methods; and exploration of computational modeling methods"

Pharmaceutical chemistry. --- Drugs --- Drug development. --- Structure-activity relationships. --- Design. --- Drug Design --- Drug Evaluation, Preclinical --- Drug-Related Side Effects and Adverse Reactions --- Pharmaceutical Preparations --- Pharmacokinetics --- Structure-Activity Relationship --- Drug design --- Pharmaceutical design --- Drug development --- Development of drugs --- New drug development --- Pharmacology --- Pharmacy --- Structure-activity relationship (Pharmacology) --- Pharmaceutical chemistry --- Structure-activity relationships (Biochemistry) --- Chemistry, Medical and pharmaceutical --- Chemistry, Pharmaceutical --- Drug chemistry --- Medical chemistry --- Medicinal chemistry --- Pharmacochemistry --- Chemistry --- Development