Philipson A
Acta Obstet Gynecol Scand. 1980;59(4):311-3. doi: 10.3109/00016348009154085.
A study protocol is described by means of which useful and pertinent information on possible alterations of pharmacokinetic parameters due to pregnancy can be investigated. Whenever any drug is prescribed to a pregnant woman for medical reasons, pharmacokinetic data for that drug can be obtained by determination of drug levels in urine, plasma or serum, or other possible tissues. The same data should later be obtained for an identical dose of the same drug given to the same woman after pregnancy. By comparing pharmacokinetic parameters in the same woman during pregnancy and after--when she serves as her own nonpregnant control--clinically and statistically significant differences may be discovered with a comparatively small patient material. As in each case the drug that is studied is prescribed for medical reasons, this protocol involves no undue risks for the pregnant woman or the fetus.
本文描述了一种研究方案，通过该方案可以调查妊娠导致的药代动力学参数可能改变的有用且相关的信息。每当出于医疗原因给孕妇开任何药物时，可以通过测定尿液、血浆或血清或其他可能组织中的药物水平来获得该药物的药代动力学数据。之后，应对该名妇女在产后给予相同剂量的同一种药物获取相同的数据。通过比较同一妇女在孕期和产后（此时她作为自己的非孕对照）的药代动力学参数，使用相对较少的患者材料就可能发现具有临床和统计学意义的差异。由于在每种情况下所研究的药物都是出于医疗原因而开具的，该方案不会给孕妇或胎儿带来不当风险。
