1. ICH (International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use) M3 (R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals; 2009. www.ICH.org.
2. Pre- and postnatal developmental toxicity study design for pharmaceuticals;Bailey;Birth Defects Res (Part B),2009
3. Juvenile animal toxicity study designs to support pediatric drug development;Cappon;Birth Defects Res (Part B),2009
4. Developmental and reproductive toxicology studies in nonhuman primates;Chellman;Birth Defects Res (Part B),2009
5. Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices;Morford;Birth Defects Res (Part B),2011