Considering the patient in pediatric drug development : how good intentions turned into harm /: how good intentions turned into harm. (2020)

• Record Type: Book
• Further Information: Note: Klaus Rose.
• Authors: Rose, Klaus, 1953-
• Contents: Rumpelstiltskin and the miller’s daughter; Conclusion and outlook; Introduction; Abbreviations and technical explanations; Background; 1. The process of modern drug development and the challenge of young patients; 2. US and EU pediatric legislation; 3. A paradigm shift; 4. Introduction: specific disease areas; 4.1 Tissue-engineered products (TEPs), advanced medicinal; 4.2 Suicide, depression, and mental disorders in young; 4.3 Cancer and malignancies in young patients; 4.4 Chronic arthritis in young and adult patients, and “Juvenile Idiopathic Arthritis” (JIA); 4.5 Diabetes; 4.6 Allergies and allergen-specific immunotherapy (ASIT) in young patients; 4.7 Epilepsy; 4.8 Multiple sclerosis; 4.9 Atopic dermatitis and psoriasis; 4.10 Cystic fibrosis; 4.11 Vaccines and antiinfectives; 5. Neonatology; 6. Challenges at the interface of science, drug development, and drug approval beyond specific disease areas; 6.1 The on-label/off-label framework in adults and young patients; 6.2 Developmental pharmacology and the globalization of the children-are-therapeutic-orphans mantra; 6.3 Extrapolation; 6.4 Daily deceit in “pediatric” studies; 6.5 Myths in today’s medical world and “pediatric” studies; 7. Juvenile animal studies; 8. Child-friendly formulations: tablets, quick-dissolving formulations, liquids, and more; 9. What do young patients really need?
• Publisher Details: Amsterdam : Academic Press
• Publication Date: 2020
• Extent: 1 online resource
• Subjects: 615.190083; Pediatric pharmacology; Drug development; Drugs -- Testing -- Safety measures
• Languages: English
• ISBNs: 9780128242056
• Related ISBNs: 9780128238882
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.