Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: A conference report

Clinical Pharmacology and Therapeutics

Volumn 69, Issue 6, 2001, Pages 387-399

  Galluppi, Gerald R ^a,b,c,d,e,f   Rogge, Mark C ^a,b,c,d,e,f   Roskos, Lorin K ^a,b,c,d,e,f   Lesko, Lawrence J ^a,b,c,d,e,f   Green, Martin D ^a,b,c,d,e,f   Feigal Jr , David W ^a,b,c,d,e,f   Peck, Carl C ^a,b,c,d,e,f  

^a PFIZER INC   (United States)

^b AMGEN INC   (United States)

^c Abgenix Inc   (United States)

^d CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^e CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^f GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HYBRID PROTEIN; IMMUNOGLOBULIN; INTERLEUKIN 12; PROTEIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

CONCENTRATION RESPONSE; CONFERENCE PAPER; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; IMMUNOGENICITY; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; TECHNIQUE; TOXICOKINETICS;

CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; DRUG APPROVAL; DRUG DESIGN; PHARMACOKINETICS; PHARMACOLOGY; PROTEINS;

EID: 0034980195     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1067/mcp.2001.115455     Document Type: Conference Paper

References (44)

1. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development
2. International Conference on Harmonisation; Guideline on the validation of analytical procedures: Methodology; availability
3. The measurement of missense errors during in vivo protein synthesis
4. Protein and peptide chemical and physical stability
5. Isolation, identification and pharmacokinetic properties of human tissue-type plasminogen activator species: Possible localization of a clearance recognition site
6. Clearance of recombinant tissue factor pathway inhibitor (TFPI) in rabbits
7. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective
8. Some validation considerations for immunoassays
9. The influence of carbohydrate structure on the clearance of recombinant tissue-type plasminogen activator
10. Immunomodulation by LFA3TIP, an LFA3/IgG1 fusion protein: Cell line dependent glycosylation effects on pharmacokinetics and pharmacodynamic markers
11. Clinical experience with recombinant human thrombopoietin in chemotherapy-induced thrombocytopenia
12. Detection and characterization of antibodies to PEG-IFN-alpha2b using surface plasmon resonance
13. Interspecies scaling, allometry, physiological time and the ground plan of pharmacokinetics
14. The pharmacokinetic principles behind scaling from preclinical results to phase I protocols
15. Interspecies scaling of clearance and volume of distribution data for five therapeutic proteins
16. Animal pharmacokinetics of the tumor necrosis factor receptor-immunoglobulin fusion protein lenercept and their extrapolation to humans
17. 1-protease-inhibitor (API) disposition after IV-infusion [abstract]
18. Physiologically based pharmacokinetic study on a cyclosporin derivative, SDZ IMM 125
19. Modeling of r-metHuG-CSF (SD/OD) mediated granulopoiesis in normal animals with mathematical extrapolation to neutropenic settings [abstract]
20. A single administration of r-metHuG-CSF-SD/01 (SD/01) significantly improves neutrophil recovery following autologous bone marrow transplantation [abstract]
21. A cytokinetic model of r-metHuG-CSF-SD/01 (SD/01) mediated granulopoiesis and the "self-regulation" of SD/01 elimination in non-small cell lung cancer (NCLSC) patients [abstract]
22. Pharmacologically-guided phase I clinical trials based upon preclinical data
23. Impaired bioavailability of interferon beta-1a when administered intramuscularly by needle-free injection
24. Relationship of effective molecular size to systemic clearance in rats of recombinant inteleukin-2 chemically modified with water-soluble polymers
25. The influence of reduced liver blood flow on the pharmacokinetics and pharmacodynamics of recombinant tissue factor pathway inhibitor
26. Nonlinear pharmacokinetics of recombinant human macrophage colony-stimulating factor (M-CSF) in rats
27. Evidence for a novel in vivo control mechanism of granulopoiesis: Mature cell-related control of a regulatory growth factor
28. Down-regulation of the pharmacokinetic-pharmacodynamic response to interleukin-12 during long-term administration to patients with renal cell carcinoma and evaluation of the mechanism of this "adaptive response" in mice
29. Effects of single-dose interleukin-12 exposure on interleukin-12-associated toxicity and interferon-gamma production
30. PEGylated recombinant human soluble tumour necrosis factor receptor type I (r-Hu-sTNF-RI): Novel high affinity TNF receptor designed for chronic inflammatory diseases
31. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients
32. Pharmacokinetics and pharmacodynamics of SB-40563, a humanized monoclonal antibody directed to human IL-5 in mild asthmatics
33. Determination of absolute bioavailability of subcutaneously administered filgrastim following single doses to healthy volunteers [abstract]
34. Cytokinetic model of platelet production and destruction following administration of PEG-rHuMGDF [abstract]
35. Correction of thrombocytopenia and ineffective platelet production in patients infected with human immunodeficiency virus (HIV) by PEG-rHuMGDF therapy [abstract]
36. Cyclic thrombocytopenia with platelet auto-antibodies: Response to PEG-rHuMegakaryocyte growth and development factor [abstract]
37. Effects of megakaryocyte growth and development factor on platelet production, platelet life span, and platelet function in normal human volunteers
38. Changes of antipyrine pharmacokinetics during influenza and after administration of interferon-alpha and -beta
39. Regulation of cytochromes P450 during inflammation and infection
40. Design of biological equivalence programs for therapeutic biotechnology products in clinical development: A perspective
41. Comparability of biotechnology products: A global approach to accelerating development and availability