Pediatric drug development: The international conference on harmonization focus on clinical investigations in children

Drug Information Journal

Volumn 34, Issue 3, 2000, Pages 809-819

  Simar, M R ^a  

^a Cerveau Consulting   (United States)

Author keywords

Drug development; Global; Guideline; Pediatric

Indexed keywords

ARTICLE; CHILD HEALTH CARE; CLINICAL TRIAL; DECISION MAKING; DRUG RESEARCH; MEDICAL ETHICS; METHODOLOGY; PATIENT CODING; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARDIZATION;

EID: 0033837949     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400317     Document Type: Article

References (59)

1. Therapeutic orphans
2. Therapeutic drug monitoring in the neonate and paediatric age group: Problems and clinical pharmacokinetic implications
3. Pharmacokinetic studies in paediatric patients: Clinical and ethical considerations
4. Role of population pharmacokinetics in drug development: A pharmaceutical industry perspective
5. Optimal sampling theory: An overview of its application to pharmacokinetic studies in infants and children
6. Developmental pharmacology: Past, present and future
7. Pharmacogenetics in pediatrics. Implications for practice
8. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients: Final rule
9. Pediatric drug formulations: A rate-limiting step
10. Lack of pediatric drug formulations
11. A spoonful of sugar helps the medicine go down? Perspectives on the use of sugar in children's medicines
12. Biopharmaceutical aspects of anti-infective therapy at the extremes of age
13. Alternative routes of drug administration: Advantages and disadvantages
14. Quality drug therapy in children: Formulations and delivery
15. Non-medicinal ingredients
16. Inactive ingredients in pharmaceutical products: Update
17. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act
18. Total bilirubin level in relation to excipients in parenteral morphine sulfate administered to seriously ill newborn infants
19. Developmental aspects of drug metabolism in children
20. Developmental pharmacodynamics of cyclosporine
21. The effect of developmental changes in adolescence on drug disposition
22. Clinical pharmacology of the perinatal period and early infancy
23. Effect of maturation on drug disposition in pediatric patients
24. Adolescent depression: A placebo-controlled fluoxetine treatment study and follow-up
25. Pharmacokinetically designed double-blind placebo-controlled study of nortriptyline in 6- to 12-year olds with major depressive disorder
26. Relative efficacy of amethocaine gel and lidocaine-prilocaine cream for Port-a-Cath puncture in children
27. Alleviation of the pain of venepuncture in neonates
28. Pharmacokinetics of anti-infective agents in paediatric patients
29. A policy regarding research in healthy children
30. Patient recruitment: US perspective
31. Indices of pain intensity: Construct validity among preschoolers
32. Validity of behavioral and physiologic parameters for acute pain assessment of term newborn infants
33. Study designs and challenges in clinical studies conducted in infants and children with asthma
34. Validation of an asthma symptom diary for interventional studies
35. Understanding and treatment of childhood depression
36. Influence of inhaled corticosteroids on growth: A pediatric endocroinologist's perspective
37. Perinatal exposure to CNS-active medications: Neurodevelopmental risks
38. Specific requirements on content and format of labeling for human prescription drugs; revision of 'Pediatric Use' subsection in the labeling; final rule
39. Developmental pharmacology: Ontogenic basis of drug disposition
40. Total theophylline clearance in childhood: The influence of age-dependent changes in metabolism and elimination
41. Pharmacogenetics and development: Are infants and children at increased risk for adverse outcomes?
42. Friendship patterns and peer status during early and middle childhood
43. The psychological functions of preadolescent peer activities
44. Impaired insulin in puberty. A contributing factor to poor glycemic control in adolescents with diabetes
45. Offering a randomized trial of intensive therapy for IDDM to adolescents. Reasons for refusal, patient characteristics and recruiter effects
46. Compliance with medical regimens during adolescence
47. Management of insulin-dependent diabetes mellitus in adolescents
48. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
49. Children's involvement in research participation decisions: Psychological considerations