-
1
-
-
41149095997
-
Preclinical development of therapeutic biologics
-
Baumann A. Preclinical development of therapeutic biologics. Expert Opin. Drug Discov. 3 (2008) 289-297
-
(2008)
Expert Opin. Drug Discov.
, vol.3
, pp. 289-297
-
-
Baumann, A.1
-
2
-
-
26944499416
-
Biopharmaceuticals: recent approvals and likely directions
-
Walsh G. Biopharmaceuticals: recent approvals and likely directions. Trends Biotechnol. 23 (2005) 553-558
-
(2005)
Trends Biotechnol.
, vol.23
, pp. 553-558
-
-
Walsh, G.1
-
3
-
-
11144334098
-
Recombinant protein therapeutics - success rates, market trends and values 2010
-
Pavlou A.K., and Reichert J.M. Recombinant protein therapeutics - success rates, market trends and values 2010. Nat. Biotechnol. 22 (2004) 1513-1519
-
(2004)
Nat. Biotechnol.
, vol.22
, pp. 1513-1519
-
-
Pavlou, A.K.1
Reichert, J.M.2
-
4
-
-
34247876138
-
Development trends for monoclonal antibody cancer therapeutics
-
Reichert J.M., and Valge-Archer V.E. Development trends for monoclonal antibody cancer therapeutics. Nat. Rev. Drug Discov. 6 (2007) 349-356
-
(2007)
Nat. Rev. Drug Discov.
, vol.6
, pp. 349-356
-
-
Reichert, J.M.1
Valge-Archer, V.E.2
-
5
-
-
34147150749
-
Emerging monoclonal antibody therapies for malignant gliomas
-
Gerber D.E., and Laterra J. Emerging monoclonal antibody therapies for malignant gliomas. Expert Opin. Investig. Drugs 16 (2007) 477-494
-
(2007)
Expert Opin. Investig. Drugs
, vol.16
, pp. 477-494
-
-
Gerber, D.E.1
Laterra, J.2
-
6
-
-
27144457667
-
Monoclonal antibody successes in the clinic
-
Reichert J.M., et al. Monoclonal antibody successes in the clinic. Nat. Biotechnol. 23 (2005) 1073-1078
-
(2005)
Nat. Biotechnol.
, vol.23
, pp. 1073-1078
-
-
Reichert, J.M.1
-
8
-
-
33644865904
-
Early development of therapeutic biologics - pharmacokinetics
-
Baumann A. Early development of therapeutic biologics - pharmacokinetics. Curr. Drug Metab. 7 (2006) 15-21
-
(2006)
Curr. Drug Metab.
, vol.7
, pp. 15-21
-
-
Baumann, A.1
-
10
-
-
33645540499
-
Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals
-
Snodin D.J., and Ryle P.R. Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals. BioDrugs 20 (2006) 25-52
-
(2006)
BioDrugs
, vol.20
, pp. 25-52
-
-
Snodin, D.J.1
Ryle, P.R.2
-
13
-
-
71749119084
-
-
FDA planned guidances for assay development for immunogenicity testing and immunogenicity assessment for therapeutic protein products
-
FDA planned guidances for assay development for immunogenicity testing and immunogenicity assessment for therapeutic protein products (http://www.fda.gov/cder/guidance/CY09.pdf)
-
-
-
-
18
-
-
53049092892
-
Nonclinical aspects of biopharmaceutical development: discussion of case studies at a PhRMA-FDA workshop
-
Buckley L.A., et al. Nonclinical aspects of biopharmaceutical development: discussion of case studies at a PhRMA-FDA workshop. Int. J. Toxicol. 27 (2008) 303-312
-
(2008)
Int. J. Toxicol.
, vol.27
, pp. 303-312
-
-
Buckley, L.A.1
-
19
-
-
0033648526
-
Nonclinical safety evaluation of biotechnology derived pharmaceuticals
-
Dempster A.M. Nonclinical safety evaluation of biotechnology derived pharmaceuticals. Biotechnol. Annu. Rev. 5 (2000) 221-258
-
(2000)
Biotechnol. Annu. Rev.
, vol.5
, pp. 221-258
-
-
Dempster, A.M.1
-
20
-
-
33748416499
-
Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412
-
Suntharalingam G., et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355 (2006) 1018-1028
-
(2006)
N. Engl. J. Med.
, vol.355
, pp. 1018-1028
-
-
Suntharalingam, G.1
-
21
-
-
54349091558
-
Safety-related regulatory actions for biologicals approved in the United States and the European Union
-
Giezen T.J., et al. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 300 (2008) 1887-1896
-
(2008)
JAMA
, vol.300
, pp. 1887-1896
-
-
Giezen, T.J.1
-
22
-
-
34447091994
-
Preclinical and clinical safety of monoclonal antibodies
-
Tabrizi M.A., and Roskos L.K. Preclinical and clinical safety of monoclonal antibodies. Drug Discov. Today 12 (2007) 540-547
-
(2007)
Drug Discov. Today
, vol.12
, pp. 540-547
-
-
Tabrizi, M.A.1
Roskos, L.K.2
-
23
-
-
37349045360
-
Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?
-
Clarke J., et al. Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?. Regul. Toxicol. Pharmacol. 50 (2008) 2-22
-
(2008)
Regul. Toxicol. Pharmacol.
, vol.50
, pp. 2-22
-
-
Clarke, J.1
-
24
-
-
84891533971
-
General toxicity testing and immunotoxicity testing for biopharmaceuticals
-
Cavagnaro J.A. (Ed), Wiley & Sons
-
Bussiere J.L. General toxicity testing and immunotoxicity testing for biopharmaceuticals. In: Cavagnaro J.A. (Ed). Preclinical Safety Evaluation of Biopharmaceuticals (2008), Wiley & Sons 343-356
-
(2008)
Preclinical Safety Evaluation of Biopharmaceuticals
, pp. 343-356
-
-
Bussiere, J.L.1
-
25
-
-
67349241946
-
Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies
-
Ponce R., et al. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol. 54 (2009) 164-182
-
(2009)
Regul. Toxicol. Pharmacol.
, vol.54
, pp. 164-182
-
-
Ponce, R.1
-
26
-
-
8144221194
-
Genetically engineered animals in drug discovery and development: a maturing resource for toxicologic research
-
Bolon B. Genetically engineered animals in drug discovery and development: a maturing resource for toxicologic research. Basic Clin. Pharmacol. Toxicol. 95 (2004) 154-161
-
(2004)
Basic Clin. Pharmacol. Toxicol.
, vol.95
, pp. 154-161
-
-
Bolon, B.1
-
27
-
-
71749105773
-
Use of animal models of disease in the preclinical safety evaluation of biopharmaceuticals
-
Cavagnaro J.A. (Ed), Wiley & Sons
-
Koppele J.T., and Witkamp R. Use of animal models of disease in the preclinical safety evaluation of biopharmaceuticals. In: Cavagnaro J.A. (Ed). Preclinical Safety Evaluation of Biopharmaceuticals (2008), Wiley & Sons 293-308
-
(2008)
Preclinical Safety Evaluation of Biopharmaceuticals
, pp. 293-308
-
-
Koppele, J.T.1
Witkamp, R.2
-
28
-
-
0033921144
-
Preclinical development of keliximab, a primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies
-
Bugelski P.J., et al. Preclinical development of keliximab, a primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies. Hum. Exp. Toxicol. 19 (2000) 230-243
-
(2000)
Hum. Exp. Toxicol.
, vol.19
, pp. 230-243
-
-
Bugelski, P.J.1
-
32
-
-
77953674828
-
Comparison of preclinical development programs for small molecules and large molecules: studies, timing, materials; and costs
-
Cavagnaro J.A. (Ed), Wiley & Sons
-
Horvath C. Comparison of preclinical development programs for small molecules and large molecules: studies, timing, materials; and costs. In: Cavagnaro J.A. (Ed). Preclinical Safety Evaluation of Biopharmaceuticals (2008), Wiley & Sons 125-159
-
(2008)
Preclinical Safety Evaluation of Biopharmaceuticals
, pp. 125-159
-
-
Horvath, C.1
-
35
-
-
4344634877
-
Pharmacokinetic aspects of biotechnology products
-
Tang L., et al. Pharmacokinetic aspects of biotechnology products. J. Pharm. Sci. 93 (2004) 2184-2204
-
(2004)
J. Pharm. Sci.
, vol.93
, pp. 2184-2204
-
-
Tang, L.1
-
37
-
-
3242892400
-
Immunogenicity of recombinant human proteins: causes and consequences
-
Schellekens H., and Casadevall N. Immunogenicity of recombinant human proteins: causes and consequences. J. Neurol. 251 (2004) II/4-II/9
-
(2004)
J. Neurol.
, vol.251
-
-
Schellekens, H.1
Casadevall, N.2
-
38
-
-
33747338728
-
Tumor necrosis factor inhibitors for rheumatrid arthritis
-
Scott D.L., and Kingsley G.H. Tumor necrosis factor inhibitors for rheumatrid arthritis. N. Engl. J. Med. 355 (2006) 704-712
-
(2006)
N. Engl. J. Med.
, vol.355
, pp. 704-712
-
-
Scott, D.L.1
Kingsley, G.H.2
-
39
-
-
33846463047
-
Non-clinical safety studies on biosimilar recombinant human erythropoietin
-
Parnham M.J., et al. Non-clinical safety studies on biosimilar recombinant human erythropoietin. Basic Clin. Pharmacol. Toxicol. 100 (2007) 73-83
-
(2007)
Basic Clin. Pharmacol. Toxicol.
, vol.100
, pp. 73-83
-
-
Parnham, M.J.1
-
40
-
-
33744950980
-
Scientific and regulatory considerations on the immunogenicity of biologics
-
Shankar G., et al. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 24 (2006) 274-280
-
(2006)
Trends Biotechnol.
, vol.24
, pp. 274-280
-
-
Shankar, G.1
-
41
-
-
41149114952
-
Immunogenicity of biopharmaceuticals in laboratory animals
-
Weirda A.D., et al. Immunogenicity of biopharmaceuticals in laboratory animals. Toxicology 98 (2001) 2599-2602
-
(2001)
Toxicology
, vol.98
, pp. 2599-2602
-
-
Weirda, A.D.1
-
42
-
-
3843149585
-
Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans
-
Bugelski P.J., and Treacy G. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. Curr. Opin. Mol. Ther. 6 (2004) 10-16
-
(2004)
Curr. Opin. Mol. Ther.
, vol.6
, pp. 10-16
-
-
Bugelski, P.J.1
Treacy, G.2
-
43
-
-
54849437047
-
Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates
-
De Groot A.S., et al. Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates. Curr. Opin. Pharmacol. 8 (2008) 620-626
-
(2008)
Curr. Opin. Pharmacol.
, vol.8
, pp. 620-626
-
-
De Groot, A.S.1
-
44
-
-
36049006592
-
Immunogenicity of protein therapeutics
-
De Groot A.S., and Scott D.W. Immunogenicity of protein therapeutics. Trends Immunol. 28 (2007) 482-490
-
(2007)
Trends Immunol.
, vol.28
, pp. 482-490
-
-
De Groot, A.S.1
Scott, D.W.2
-
45
-
-
33847732132
-
Immunogenicity screening in protein drug development
-
Van Walle I., et al. Immunogenicity screening in protein drug development. Expert Opin. Biol. Ther. 7 (2007) 405-418
-
(2007)
Expert Opin. Biol. Ther.
, vol.7
, pp. 405-418
-
-
Van Walle, I.1
-
46
-
-
66949133262
-
Current approaches to stabilising and analysing proteins during microencapsulation in PLGA
-
Van der Walle C.F., et al. Current approaches to stabilising and analysing proteins during microencapsulation in PLGA. Expert Opin. Drug Deliv. 6 (2009) 177-186
-
(2009)
Expert Opin. Drug Deliv.
, vol.6
, pp. 177-186
-
-
Van der Walle, C.F.1
-
47
-
-
8644234910
-
Antibody pharmacokinetics and pharmacodynamics
-
Lobo E.D., et al. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci. 93 (2004) 2645-2668
-
(2004)
J. Pharm. Sci.
, vol.93
, pp. 2645-2668
-
-
Lobo, E.D.1
-
48
-
-
0030017103
-
The relevance of pharmacokinetics in the development of biotechnology drugs
-
Toon S. The relevance of pharmacokinetics in the development of biotechnology drugs. Eur. J. Drug 21 (1996) 93-103
-
(1996)
Eur. J. Drug
, vol.21
, pp. 93-103
-
-
Toon, S.1
-
49
-
-
49449119098
-
Antibody-drug conjugates for cancer therapy
-
Carter P.J., and Senter P.D. Antibody-drug conjugates for cancer therapy. Cancer J. 74 (2008) 154-169
-
(2008)
Cancer J.
, vol.74
, pp. 154-169
-
-
Carter, P.J.1
Senter, P.D.2
-
50
-
-
33845938292
-
PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies
-
Webster R., et al. PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. Drug Metab. Dispos. 35 (2007) 9-16
-
(2007)
Drug Metab. Dispos.
, vol.35
, pp. 9-16
-
-
Webster, R.1
-
51
-
-
36148968010
-
Drug interaction studies of therapeutic proteins or monoclonal antibodies
-
Mahmood I., and Green M.D. Drug interaction studies of therapeutic proteins or monoclonal antibodies. J. Clin. Pharmacol. 47 (2007) 1540-1554
-
(2007)
J. Clin. Pharmacol.
, vol.47
, pp. 1540-1554
-
-
Mahmood, I.1
Green, M.D.2
-
52
-
-
41149106199
-
Pharmacokinetic drug drug interaction potentials for therapeutic monoclonal antibodies: reality check
-
Seitz K., and Zhou H. Pharmacokinetic drug drug interaction potentials for therapeutic monoclonal antibodies: reality check. J. Clin. Pharmacol. 47 (2007) 1104-1118
-
(2007)
J. Clin. Pharmacol.
, vol.47
, pp. 1104-1118
-
-
Seitz, K.1
Zhou, H.2
-
53
-
-
69749119482
-
Risk-based strategy for the assessment of pharmacokinetic drug-drug interactions for therapeutic monoclonal antibodies
-
Zhou H., and Davis H.M. Risk-based strategy for the assessment of pharmacokinetic drug-drug interactions for therapeutic monoclonal antibodies. Drug Discov. Today 14 (2009) 891-898
-
(2009)
Drug Discov. Today
, vol.14
, pp. 891-898
-
-
Zhou, H.1
Davis, H.M.2
-
54
-
-
32444438731
-
Elimination mechanism of therapeutic monoclonal antibodies
-
Tabrizi M.A., et al. Elimination mechanism of therapeutic monoclonal antibodies. Drug Discov. Today 11 (2006) 81-88
-
(2006)
Drug Discov. Today
, vol.11
, pp. 81-88
-
-
Tabrizi, M.A.1
-
55
-
-
34548028700
-
Population pharmacokinetics-pharmacodynamics of alemtuzuMAb in patients with chronic lymphcytic leukaemia and its link to treatment response
-
Mould D.R., et al. Population pharmacokinetics-pharmacodynamics of alemtuzuMAb in patients with chronic lymphcytic leukaemia and its link to treatment response. Br. J. Clin. Pharmacol. 64 (2007) 278-291
-
(2007)
Br. J. Clin. Pharmacol.
, vol.64
, pp. 278-291
-
-
Mould, D.R.1
-
57
-
-
71749111581
-
Predicting human pharmacokinetics of mAbs with linear and non-linear elimination based only on monkey data; Poster presentation
-
Seattle, June
-
Dong J.Q., et al. Predicting human pharmacokinetics of mAbs with linear and non-linear elimination based only on monkey data; Poster presentation. NBC-AAPS Meeting. Seattle, June (2009) 21-24
-
(2009)
NBC-AAPS Meeting
, pp. 21-24
-
-
Dong, J.Q.1
-
58
-
-
67649209050
-
Discovery DMPK: changing paradigms in the eighties, nineties and noughties
-
Summerfield S., and Jeffrey P. Discovery DMPK: changing paradigms in the eighties, nineties and noughties. Expert Opin. Drug Discov. 4 (2009) 207-218
-
(2009)
Expert Opin. Drug Discov.
, vol.4
, pp. 207-218
-
-
Summerfield, S.1
Jeffrey, P.2
-
59
-
-
67649207267
-
Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates
-
Yeung Y.A., et al. Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates. J. Immunol. (2009) 7663-7671
-
(2009)
J. Immunol.
, pp. 7663-7671
-
-
Yeung, Y.A.1
-
60
-
-
3042810417
-
Mass spectrometric approaches for protein quantitation in drug development
-
Qin C.J., et al. Mass spectrometric approaches for protein quantitation in drug development. Am. Pharm. Rev. 7 (2004) 4-89
-
(2004)
Am. Pharm. Rev.
, vol.7
, pp. 4-89
-
-
Qin, C.J.1
-
61
-
-
10744230729
-
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
-
DeSilva B., et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (2003) 1885-1900
-
(2003)
Pharm. Res.
, vol.20
, pp. 1885-1900
-
-
DeSilva, B.1
-
62
-
-
0142039654
-
Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals
-
Wadhwa M., et al. Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals. J. Immunol. Methods 278 (2003) 1-17
-
(2003)
J. Immunol. Methods
, vol.278
, pp. 1-17
-
-
Wadhwa, M.1
-
63
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
Mire-Sluis A.R., et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289 (2004) 1-16
-
(2004)
J. Immunol. Methods
, vol.289
, pp. 1-16
-
-
Mire-Sluis, A.R.1
-
64
-
-
33947397632
-
Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
-
Gupta S., et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J. Immunol. Methods 321 (2007) 1-18
-
(2007)
J. Immunol. Methods
, vol.321
, pp. 1-18
-
-
Gupta, S.1
-
65
-
-
41149118788
-
Assays for the detection of antibodies - current scientific challenges
-
Brown F., and Mire-Sluis A.R. (Eds), Karger
-
Indelicato S.R. Assays for the detection of antibodies - current scientific challenges. In: Brown F., and Mire-Sluis A.R. (Eds). Immunogenicity of Therapeutic Biological Products (2003), Karger 105-139
-
(2003)
Immunogenicity of Therapeutic Biological Products
, pp. 105-139
-
-
Indelicato, S.R.1
-
66
-
-
41349116947
-
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
-
Koren E., et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 333 (2008) 1-9
-
(2008)
J. Immunol. Methods
, vol.333
, pp. 1-9
-
-
Koren, E.1
-
67
-
-
58249116651
-
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
-
Shankar G., et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48 (2008) 1267-1281
-
(2008)
J. Pharm. Biomed. Anal.
, vol.48
, pp. 1267-1281
-
-
Shankar, G.1
-
68
-
-
34249684926
-
A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
-
Shankar G., et al. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 25 (2007) 555-561
-
(2007)
Nat. Biotechnol.
, vol.25
, pp. 555-561
-
-
Shankar, G.1
-
69
-
-
10944231251
-
A risk-based approach to immunogenicity concerns of therapeutic protein products. Part 1: considering consequences of the immune response to a protein
-
Rosenberg A.S., and Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products. Part 1: considering consequences of the immune response to a protein. Biopharm. Int. 17 (2004) 34-42
-
(2004)
Biopharm. Int.
, vol.17
, pp. 34-42
-
-
Rosenberg, A.S.1
Worobec, A.2
|