Towards Earlier Involvement of Children and Pregnant Women in Trials of New TB Drugs

EMA Documents

Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

Juvenile Animal Studies for the Development of Paediatric Medicines: A Description and Conclusions From a European Medicines Agency Workshop on Juvenile Animal Testing for Nonclinical Assessors

Guidelines

Guideline on the Exposure to Medicinal Products During Pregnancy: Need for Post Authorisation Data

Guidelines on Pharmacovigilance for Medicinal Products for Human Use

Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population

Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections to Specifically Address the Clinical Development of New Agents to Treat Disease due to Mycobacterium Tuberculosis

EC Pediatric Regulations

Guideline on the Need for Non-clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications

Concept paper on extrapolation of efficacy and safety in medicine development

Guideline on Clinical Trials in Small Populations

Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population

Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Popluation

Guideline on Conduct of Pharmacovigilance for Medicines used by the Paediatric Population

ICH Guidelines

Clinical Investigation of Medicinal Products in the Paediatric Population

The Clinical Evaluation of QT/QTC Interval Prolongation and Proarrythmic Potential for Nonantiarrhythmic Drugs

Dose Response Information to Support Drug Registration

Pharmacovigilance Planning

The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions

Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility

Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

WHO Documents

Towards universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis by 2015

Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access

Treatment of Tuberculosis Guidelines

Development of Paediatric Medicines: Points to Consider in Pharmaceutical Development

Rapid Advice: Treatment of Tuberculosis in Children

Childhood Tuberculosis

Tuberculosis & Child Health

Excellent resources for more information

Clinical Guidance for Pediatric TB

Towards Earlier Involvement of Children and Pregnant Women in Trials of New TB Drugs