Table 5.
Scientific guidelines for pediatric drug development.
| International Guidelines |
| • Note for Guidance on Clinical Investigation of Medicinal Products in the Pediatric Population (ICH, E11) [17] |
| FDA Pediatric Guidelines |
| • General Considerations for the Clinical Evaluation of Drugs in Infants and Children [38] |
| • General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products [26] |
| • Nonclinical Safety Evaluation of Pediatric Drug Products [39] |
| • Guidelines for the Clinical Evaluation of Antiepileptic Drugs (Adults and Children) [40] |
| • Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children [41] |
| • Guidelines for the Clinical Evaluation of Psychoactive Drugs in Infants and Children [42] |
| • Pediatric Oncology Studies in Response to a Written Request (Draft Guidance) [43] |
| EMA Pediatric Guidelines |
| • Guideline on the role of pharmacokinetics in the development of medicinal products in the pediatric population [44] |
| • Guideline on the investigation of medicinal products in the term and preterm neonate [45] |
| • Guideline on conduct of pharmacovigilance for medicines used by the pediatric population [46] |
| • Note for guidance on evaluation of anticancer medicinal products in man - Addendum on pediatric oncology [47] |
| • Clinical evaluation of medicinal products in weight control - Addendum on weight control in children [48] |
| • Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for pediatric indications [49] |
| • Concept paper on the impact of brain immaturity when investigating medicinal products intended for neonatal use [50] |
| • Concept paper on the impact of liver immaturity when investigating medicinal products intended for neonatal use (draft) [51] |
| • Concept paper on the impact of lung and heart immaturity when investigating medicinal products intended for neonatal use (draft) [52] |
| • Pediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (draft) [53] |
| • Pediatric addendum to the CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (draft) [54] |
| • Concept paper on the need for the development of a pediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension [55] |
| • Ethical considerations for clinical trials on medicinal products with the pediatric population [56] |
| • Discussion paper on the impact of renal immaturity when investigating medicinal products intended for pediatric use [57] |
| • Reflection paper: formulations of choice for the pediatric population [58] |