US FDA/Center for Veterinary Medicine, Rockville, Maryland 20855, USA.
AAPS J. 2011 Dec;13(4):632-49. doi: 10.1208/s12248-011-9303-8. Epub 2011 Oct 5.
Depending upon the drug and drug delivery platform, species-specific physiological differences can lead to errors in the interspecies extrapolation of drug performance. This manuscript provides an overview of the species-specific physiological variables that can influence the performance of parenteral dosage forms such as in situ forming delivery systems, nanoparticles, microspheres, liposomes, targeted delivery systems, lipophilic solutions, and aqueous suspensions. Also discussed are those factors that can influence the partitioning of therapeutic compounds into tumors, the central nervous system and the lymphatics. Understanding interspecies differences in the movement and absorption of molecules is important to the interpretation of data generated through the use of animal models when studying parenteral drug delivery.
根据药物和药物传递平台的不同，种属特异性的生理差异可能导致药物性能的种间外推出现错误。本文概述了影响各种剂型（如原位形成给药系统、纳米粒、微球、脂质体、靶向给药系统、亲脂性溶液和水混悬剂）性能的种属特异性生理变量。本文还讨论了那些可能影响治疗化合物在肿瘤、中枢神经系统和淋巴系统中分配的因素。理解分子在种属间的移动和吸收差异，对于解释通过动物模型研究给药时产生的数据非常重要。
