Comparative pharmacokinetics, safety, and tolerability after subcutaneous administration of recombinant human erythropoietin formulated with different stabilizers

Biopharmaceutics and Drug Disposition

Volumn 21, Issue 6, 2000, Pages 211-219

  Cheung, Wing K ^a   Natarajan, Jaya ^a   Sanders, Marilyn ^a   Vercammen, Els ^b  

^a R W JOHNSON PHARMACEUTICAL RES I   (United States)

^b RW Johnson Pharmaceutical Research Institute ^*  (United States)

Author keywords

Comparative pharmacokinetics; Recombinant human erythropoietin; Safety; Tolerability

Indexed keywords

BUFFER; GLYCINE; HUMAN SERUM ALBUMIN; PARACETAMOL; PHOSPHATE; POLYSORBATE 80; RECOMBINANT ERYTHROPOIETIN; STABILIZING AGENT;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG FORMULATION; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; HEADACHE; HUMAN; INFLUENZA; INJECTION PAIN; INJECTION SITE; MALE; MYALGIA; PAIN ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SKIN DISEASE; STATISTICS; VOLUNTEER;

ADOLESCENT; ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; ERYTHROPOIETIN, RECOMBINANT; EXCIPIENTS; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; RADIOIMMUNOASSAY;

EID: 0034448232     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.231     Document Type: Article

References (16)

1. Localization of erythropoietin synthesizing cells in murine kidneys by in situ hybridization
2. Isolation and characterization of genomic and cDNA clones of human erythropoietin
3. Cloning and expression of the human erythropoietin gene
4. Erythropoietin: Structure, control of production, and function
5. Characterization of recombinant monkey and human erythropoietin
6. Characterization and biological effects of recombinant human erythropoietin
7. Epoetin (Recombinant Human Erythropoietin): A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in anemia and the stimulation of erythropoiesis
8. Epoetin alfa: A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in nonrenal applications
9. The use of nonparametric methods in the statistical analysis of the two-period changeover design
10. Pharmacokinetics and pharmacodynamics of recombinant human erythropoietin after single and multiple subcutaneous doses to healthy subjects
11. One year of r-HuEPO therapy prolongs RBC survival and may stabilize RBC membranes despite natural progression of chronic renal failure to uremia and need for dialysis
12. Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta
13. Pharmacokinetics of intraperitoneal, intravenous, and subcutaneous recombinant human erythropoietin in patients on continuous ambulatory peritoneal dialysis
14. Pharmacokinetics and effects of recombinant human erythropoietin after intravenous and subcutaneous injections in healthy volunteers
15. The pharmacokinetics of recombinant human erythropoietin after intravenous and subcutaneous administration to healthy subjects