Association of Inhalation Toxicologists' (AIT) review of regulatory aspects for inhalation toxicology studies.
Regulatory guidelines are intended to provide recommendations on ways to achieve greater harmonization in the interpretation and application of technical procedures and requirements for product registration in order to reduce or obviate replication of the testing carried out during the research and development of new products. The objectives of such harmonization are more economical use of human, animal and material resources; the elimination of unnecessary delay in the global development and availability of new products while maintaining safeguards on quality, safety and efficacy; and the fulfillment of regulatory obligations to protect public health.
Medicines and Healthcare Products Regulatory Agency, London, UK. david.jones@mhra.gsi.gov.uk
David R
DR
Jones
Paul
P
Baldrick
D000280:Administration, Inhalation; D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D012958:Societies, Scientific; D018675:Toxicity Tests / Q000592:standards*
D004364:Pharmaceutical Preparations