總結(jié)國(guó)內(nèi)外批準(zhǔn)上市和研發(fā)中微球劑型的藥理毒理研究和評(píng)價(jià)情況。根據(jù)已上市微球制劑研發(fā)中所進(jìn)行的藥理毒理研究信息，總結(jié)微球制劑非臨床藥理毒理研究中需關(guān)注的研究?jī)?nèi)容和試驗(yàn)要求。希望微球制劑研究者能夠根據(jù)微球制劑的開發(fā)目的和特點(diǎn)，開展完善合理的臨床前藥理毒理研究，以闡明開發(fā)微球制劑的藥理毒理特點(diǎn)，將微球制劑開發(fā)成為臨床需要且特點(diǎn)明顯的新藥。

Preclinical studies and evaluation on pharmaco-toxicology of microsphere products approved to the market both domestic and abroad were outlined. According to the pharmaco-toxicologic information on prenclinical studies of microsphere drugs in market, the research and experimental requirements were concerned. Adequate preclinical studies should be designed to clarify the potential clinical benefit and/or develop the new drugs with the characteristics of microsphere products.