With respect to a article published recently, officers from the US Food and Drug Administration (FDA) say that studies looking at the effects of drugs in juvenile animal populations in opposition to their effects in adult animals are usually not helpful in guiding pediatric clinical development, particularly if such research hold up the launch of a clinical trial.
The authors of the article, John Leighton, Haleh Saber, Gregory Reaman and Richard Pazdur, of US FDA's Office of Hematology and Oncology Products (OHOP) in the Center for Drug Evaluation and Research, arrived at their conclusion following analyzing data from both publicly accessible and non-public juvenile animal studies presented to the FDA to support pediatric oncology research.
FDA and ICH Guidance
In 2006, FDA released its guidance, Nonclinical Safety Evaluation of Pediatric Drug Products, to assist sponsors design non-clinical research in animals to evaluate whether drugs' effects are distinct in children in comparison to adults, in scenarios where it would be unethical or complicated to evaluate in pediatric studies.
Later, in 2010, the International Conference on Harmonization (ICH) designed its guidance, ICH S9: Nonclinical Evaluation for Anticancer Pharmaceuticals, which makes suggestions on what kinds of non-clinical research need to be performed prior to …show more content…
Two papers, The value of juvenile animal studies: "What have we learned from preclinical juvenile toxicity studies? II" and Juvenile animal testing in drug development--is it useful? discuss whether such studies offer helpful or actionable data, while one more paper, Use of juvenile animal studies to support oncology medicine development in children, states that the data are helpful, as nearly a one fourth of drugs the author analyzed revealed some variations in toxicity among adult and juvenile
The authors of the article, John Leighton, Haleh Saber, Gregory Reaman and Richard Pazdur, of US FDA's Office of Hematology and Oncology Products (OHOP) in the Center for Drug Evaluation and Research, arrived at their conclusion following analyzing data from both publicly accessible and non-public juvenile animal studies presented to the FDA to support pediatric oncology research.
FDA and ICH Guidance
In 2006, FDA released its guidance, Nonclinical Safety Evaluation of Pediatric Drug Products, to assist sponsors design non-clinical research in animals to evaluate whether drugs' effects are distinct in children in comparison to adults, in scenarios where it would be unethical or complicated to evaluate in pediatric studies.
Later, in 2010, the International Conference on Harmonization (ICH) designed its guidance, ICH S9: Nonclinical Evaluation for Anticancer Pharmaceuticals, which makes suggestions on what kinds of non-clinical research need to be performed prior to …show more content…
Two papers, The value of juvenile animal studies: "What have we learned from preclinical juvenile toxicity studies? II" and Juvenile animal testing in drug development--is it useful? discuss whether such studies offer helpful or actionable data, while one more paper, Use of juvenile animal studies to support oncology medicine development in children, states that the data are helpful, as nearly a one fourth of drugs the author analyzed revealed some variations in toxicity among adult and juvenile