Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity
نویسندگان
چکیده
منابع مشابه
Pediatric exclusivity and other contemporary regulatory changes: impact on pediatric drug study, labeling and safety
Historically, most drugs have been used ‘off-label’ in children due to a lack of specific information on dosing, safety and efficacy. This practice risks adverse events, leading to serious public health consequences. Regulatory changes have attempted to address such issues by mandating and incentivizing the study of drugs in children. By all accounts, these regulatory changes have been enormous...
متن کاملSocietal impact of extending market exclusivity for conventional drugs.
without prior written permission from the Publisher. All rights reserved. or mechanical, including photocopying or by information storage or retrieval systems, may be reproduced, displayed, or transmitted in any form or by any means, electronic States copyright law (Title 17, U.S. Code), no part of by Project HOPE The People-to-People Health Foundation. As provided by United Suite 600, Bethesda...
متن کاملA Review on Therapeutic Drug Monitoring of Immunosuppressant Drugs
Immunosuppressants require therapeutic drug monitoring because of their narrow therapeutic index and significant inter-individual variability in blood concentrations. This variability can be because of factors like drug-nutrient interactions, drug-disease interactions, renal-insufficiency, inflammation and infection, gender, age, polymorphism and liver mass. Drug monitoring is widely practiced ...
متن کاملAdopt IP Protections to ensure Regulatory exclusivity for Orphan Drugs
orphan drugs present unique risks — the potential return on investment is inherently constrained by small patient populations and attendant reimbursement challenges. recognizing these challenges, some countries have passed laws designed to make the economic model associated with developing treatments for orphan diseases more attractive. the most meaningful incentive provided by the various orph...
متن کاملEfficacy and safety of 120 w greenlight photoselective vaporisation of prostate in patients receiving anticoagulant drugs.
OBJECTIVE To evaluate the efficacy and safety of photoselective prostate vapourisation with 120 w potassium titanyl phosphate laser in benign prostate hyperplasia patients receiving oral anti-coagulant therapy. METHODS The retrospective study was conducted at Istanbul Hisar International Hosptial and comprised 63 male patients who were on anti-coagulant therapy for comorbidities and who under...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: PEDIATRICS
سال: 2008
ISSN: 0031-4005,1098-4275
DOI: 10.1542/peds.2008-0585