Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development

How Good Intentions Turned Into Harm

Rose, Klaus

Elsevier Science Publishing Co Inc

11/2020

414

Mole

Inglês

9780128238882

15 a 20 dias

630

Descrição não disponível.
Rumpelstiltskin and the miller's daughterConclusion 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 medicinal4.2 Suicide, depression, and mental disorders in young4.3 Cancer and malignancies in young patients4.4 Chronic arthritis in young and adult patients, and "Juvenile Idiopathic Arthritis? (JIA)4.5 Diabetes4.6 Allergies and allergen-specific immunotherapy (ASIT) in young patients4.7 Epilepsy4.8 Multiple sclerosis4.9 Atopic dermatitis and psoriasis4.10 Cystic fibrosis4.11 Vaccines and antiinfectives5. 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 patients6.2 Developmental pharmacology and the globalization of the children-are-therapeutic-orphans mantra6.3 Extrapolation6.4 Daily deceit in "pediatric? studies6.5 Myths in today's medical world and "pediatric? studies7. Juvenile animal studies8. Child-friendly formulations: tablets, quick-dissolving formulations, liquids, and more9. What do young patients really need?
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?Animals; Babies; Better medicines for children; Biologic; Child; Child-friendly formulations; Children are not small adults; Children as therapeutic orphans; Clinical studies; Copernicus; Dose finding in young patients; Drug development; EU pediatric legislation; Extrapolation; Galileo Galilei; Health care; Humans; Juvenile animal studies; Laboratory; Lawmakers; Medicine; Neonatology; Newborns; Off-label use of drugs in children; Olid formulations vs liquids; Pediatric drug development; Pediatric legislation; Pediatric oncology; Pharmacology; Preterm newborns; Skin; Therapeutic orphans; Toxicities; US legal culture; Viagra