title: Requirements for the clinical evaluation of new anti-tuberculosis agents in children.
abstract: The ultimate goal of evidence-based drug treatment is to produce a desired pharmacological response in a predictable manner and also to minimise adverse effects. This goal requires not only an increased awareness of the need to provide specific dosing recommendations aimed at specific patient groups, but also the implementation of a consistent integrative approach to recognise all factors contributing to the within- and between-subject variability in drug disposition and response. The assessment of new anti-tuberculosis agents and regimens in children requires a specific programme of investigation, and should be included early in human drug evaluation programmes. Appreciation of this principle is an important step forward towards the full integration of children into the tuberculosis research agenda and control programmes. The development of anti-tuberculosis drug formulations and regimens tailored to the requirements of children needs to consider physiological age-related differences for pharmacokinetics and toxicity between adults and children. Research based on these principles will create an evidence base that will inform the appropriate treatment of children with novel agents and regimens and will also inform future research, including the use of chemoprophylaxis and treatment-shortening strategies in children.
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa. prd@sun.ac.za
authors.forename: P R
authors.initials: PR
authors.lastname: Donald
authors.forename: A
authors.initials: A
authors.lastname: Ahmed
authors.forename: W J
authors.initials: WJ
authors.lastname: Burman
authors.forename: M F
authors.initials: MF
authors.lastname: Cotton
authors.forename: S M
authors.initials: SM
authors.lastname: Graham
authors.forename: C
authors.initials: C
authors.lastname: Mendel
authors.forename: H
authors.initials: H
authors.lastname: McIlleron
authors.forename: W R
authors.initials: WR
authors.lastname: Mac Kenzie
authors.forename: S
authors.initials: S
authors.lastname: Nachman
authors.forename: H S
authors.initials: HS
authors.lastname: Schaaf
authors.forename: J R
authors.initials: JR
authors.lastname: Starke
authors.forename: C
authors.initials: C
authors.lastname: Wingfield
authors.forename: A C
authors.initials: AC
authors.lastname: Hesseling
mesh_terms: D000328:Adult; D000367:Age Factors; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D019317:Evidence-Based Medicine; D006801:Humans; D012107:Research Design; D014376:Tuberculosis / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents