PMID- 8436212 OWN - NLM STAT- MEDLINE DCOM- 19930323 LR - 20190909 IS - 0902-4441 (Print) IS - 0902-4441 (Linking) VI - 50 IP - 1 DP - 1993 Jan TI - Comparative pharmacokinetics of single-dose administration of mammalian and bacterially-derived recombinant human granulocyte-macrophage colony-stimulating factor. PG - 32-6 AB - Pharmacokinetics of recombinant human non-glycosylated bacterially-synthesized (E. coli) granulocyte-macrophage colony-stimulating factor (GM-CSF) were studied following single intravenous (i.v.) and subcutaneous (s.c.) bolus injection, and compared to equivalent doses of glycosylated mammalian-derived CHO-GM-CSF. Each route of administration gave a different GM-CSF concentration-time profile. The highest peak serum concentrations (Cmax) were observed following i.v. bolus injection. After i.v. administration, a two-phase decline in concentration was noted for both types of GM-CSF with a significantly shorter t1/2 alpha of 7.8 minutes for the E. coli GM-CSF versus 20.0 min for the CHO-GM-CSF, while no significant difference was observed for the terminal phase. Following s.c. administration of equivalent doses, a higher peak serum concentration was observed in the E. coli-treated patients and, again, a faster elimination where pretreatment serum levels were reached after 16-20 h, versus more than 48 h after administration of CHO-GM-CSF. Although the non-glycosylated E. coli GM-CSF thus seems to undergo a faster elimination that the glycosylated CHO-GM-CSF no significant difference could be demonstrated in the in vivo effect of corresponding doses of the two compounds with respect to stimulation of granulopoiesis--with reservation for small patient numbers and a large individual variations in response. FAU - Hovgaard, D AU - Hovgaard D AD - Department of Hematology, Rigshospitalet, Copenhagen, Denmark. FAU - Mortensen, B T AU - Mortensen BT FAU - Schifter, S AU - Schifter S FAU - Nissen, N I AU - Nissen NI LA - eng PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Eur J Haematol JT - European journal of haematology JID - 8703985 RN - 0 (Recombinant Proteins) RN - 83869-56-1 (Granulocyte-Macrophage Colony-Stimulating Factor) SB - IM MH - Animals MH - CHO Cells/metabolism MH - Cricetinae MH - Escherichia coli/metabolism MH - Glycosylation MH - Granulocyte-Macrophage Colony-Stimulating Factor/administration & dosage/*pharmacokinetics/therapeutic use MH - Half-Life MH - Humans MH - Injections, Intravenous MH - Injections, Subcutaneous MH - Kinetics MH - Leukocyte Count MH - Lymphoma/*blood/drug therapy MH - Neutrophils/drug effects MH - Recombinant Proteins/administration & dosage/pharmacokinetics/therapeutic use EDAT- 1993/01/01 00:00 MHDA- 1993/01/01 00:01 CRDT- 1993/01/01 00:00 PHST- 1993/01/01 00:00 [pubmed] PHST- 1993/01/01 00:01 [medline] PHST- 1993/01/01 00:00 [entrez] AID - 10.1111/j.1600-0609.1993.tb00071.x [doi] PST - ppublish SO - Eur J Haematol. 1993 Jan;50(1):32-6. doi: 10.1111/j.1600-0609.1993.tb00071.x.