-
1
-
-
14844285410
-
The therapeutic antibodies market to 2008
-
A.K. Pavlou and M.J. Belsey (2005) The therapeutic antibodies market to 2008. Eur. J. Pharm. Biopharm. 59 389-396.
-
(2005)
Eur. J. Pharm. Biopharm.
, vol.59
, pp. 389-396
-
-
Pavlou, A.K.1
Belsey, M.J.2
-
3
-
-
85147085222
-
-
Ltd., Korea Advanced Inst Sci & Tech, Korea. Publication:, WO9854336 (1998)–12–03
-
K. Sun-Chang, L.J. Hyun, K.M. Hyung, K.J. Hyun, H. Seung-Suh, L. Hyun-Soo, Method for mass production of antimicrobial peptide. Patent applicant: Samyang Genex Co. Ltd., Korea Advanced Inst Sci & Tech, Korea. Publication: WO9854336 (1998)–12–03.
-
Method for mass production of antimicrobial peptide. Patent applicant: Samyang Genex Co.
-
-
Sun-Chang, K.1
Hyun, L.J.2
Hyung, K.M.3
Hyun, K.J.4
Seung-Suh, H.5
Hyun-Soo, L.6
-
5
-
-
66949133262
-
Current approaches to stabilising and analysing proteins during microencapsulation in PLGA
-
C.F. van der Walle, G. Sharma and M. Ravi Kumar (2009) Current approaches to stabilising and analysing proteins during microencapsulation in PLGA. Expert Opin. Drug Deliv. 6 177-186.
-
(2009)
Expert Opin. Drug Deliv.
, vol.6
, pp. 177-186
-
-
van der Walle, C.F.1
Sharma, G.2
Ravi Kumar, M.3
-
6
-
-
40549096422
-
The clinical effectiveness and cost-effectiveness of inhaled insulin in diabetes mellitus: A systematic review and economic evaluation
-
C. Black, E. Cummins, P. Royle, S. Philip and N. Waugh (2007) The clinical effectiveness and cost-effectiveness of inhaled insulin in diabetes mellitus: A systematic review and economic evaluation. Health Technol. Assess. 11 1-126.
-
(2007)
Health Technol. Assess.
, vol.11
, pp. 1-126
-
-
Black, C.1
Cummins, E.2
Royle, P.3
Philip, S.4
Waugh, N.5
-
7
-
-
0032488888
-
Crystallographic structure of an intact IgG1 monoclonal antibody
-
L.J. Harris, E. Skaletsky and A. McPherson (1998) Crystallographic structure of an intact IgG1 monoclonal antibody. J. Mol. Biol. 275 861-872.
-
(1998)
J. Mol. Biol.
, vol.275
, pp. 861-872
-
-
Harris, L.J.1
Skaletsky, E.2
McPherson, A.3
-
8
-
-
85147054873
-
Particulate Matter in Injections In The United States Pharmacopeia –National Formulary
-
<788>
-
U.S. Pharmacopeia. Particulate Matter in Injections In The United States Pharmacopeia –National Formulary, General Chapter <788>. (2010).
-
(2010)
General Chapter
-
-
Pharmacopeia, U.S.1
-
9
-
-
70449712980
-
Best practices for formulation and manufacturing of biotech drug products: how to maintain product stability and prevent particulates
-
S.K. Singh, N. Rathore, A. McAuley and A.S. Rathore (2009) Best practices for formulation and manufacturing of biotech drug products: how to maintain product stability and prevent particulates. BioPharm Int. 22(6),
-
(2009)
BioPharm Int.
, vol.22
, Issue.6
-
-
Singh, S.K.1
Rathore, N.2
McAuley, A.3
Rathore, A.S.4
-
10
-
-
0030725266
-
Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: Role in restricted conformational mobility and compaction of native state
-
B.S. Kendrick, B.S. Chang, T. Arakawa, B. Peterson, T.W. Randolph, M.C. Manning, et al. (1997) Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: Role in restricted conformational mobility and compaction of native state. Proc. Natl. Acad. Sci. U.S.A. 94 11917-11922.
-
(1997)
Proc. Natl. Acad. Sci. U.S.A.
, vol.94
, pp. 11917-11922
-
-
Kendrick, B.S.1
Chang, B.S.2
Arakawa, T.3
Peterson, B.4
Randolph, T.W.5
Manning, M.C.6
-
11
-
-
38349105897
-
Controlled antibody immobilization onto immunoanalytical platforms by synthetic peptide
-
Y. Jung, H.J. Kang, J.M. Lee, S.O. Jung, W.S. Yun, S.J. Chung, et al. (2008) Controlled antibody immobilization onto immunoanalytical platforms by synthetic peptide. Anal. Biochem. 374 99-105.
-
(2008)
Anal. Biochem.
, vol.374
, pp. 99-105
-
-
Jung, Y.1
Kang, H.J.2
Lee, J.M.3
Jung, S.O.4
Yun, W.S.5
Chung, S.J.6
-
12
-
-
0033562141
-
Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding
-
S.D. Allison, B. Chang, T.W. Randolph and J.F. Carpenter (1999) Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding. Arch. Biochem. Biophys. 365 289-298.
-
(1999)
Arch. Biochem. Biophys.
, vol.365
, pp. 289-298
-
-
Allison, S.D.1
Chang, B.2
Randolph, T.W.3
Carpenter, J.F.4
-
13
-
-
0032782071
-
Instability, stabilization, and formulation of liquid protein pharmaceuticals
-
W. Wang (1999) Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int. J. Pharm. 185 129-188.
-
(1999)
Int. J. Pharm.
, vol.185
, pp. 129-188
-
-
Wang, W.1
-
14
-
-
1242314686
-
Design of freeze-drying processes for pharmaceuticals: Practical advice
-
X. Tang and M.J. Pikal (2004) Design of freeze-drying processes for pharmaceuticals: Practical advice. Pharm. Res. 21 191-200.
-
(2004)
Pharm. Res.
, vol.21
, pp. 191-200
-
-
Tang, X.1
Pikal, M.J.2
-
15
-
-
39149134333
-
Elements of quality by design in development and scale-up of freeze-dried parenterals
-
S.L. Nail and J.A. Searles (2008) Elements of quality by design in development and scale-up of freeze-dried parenterals. BioPharm Int. 21(1),
-
(2008)
BioPharm Int.
, vol.21
, Issue.1
-
-
Nail, S.L.1
Searles, J.A.2
-
16
-
-
54949102798
-
Effect of freeze-dryer design on drying rate of an amorphous protein-formulation determined with a gravimetric technique
-
H. Gieseler and G. Lee (2008) Effect of freeze-dryer design on drying rate of an amorphous protein-formulation determined with a gravimetric technique. Pharm. Dev. Technol. 13 463-472.
-
(2008)
Pharm. Dev. Technol.
, vol.13
, pp. 463-472
-
-
Gieseler, H.1
Lee, G.2
-
17
-
-
0030770631
-
Rational design of stable lyophilized protein formulations: Some practical advice
-
J.F. Carpenter, M.J. Pikal, B.S. Chang and T.W. Randolph (1997) Rational design of stable lyophilized protein formulations: Some practical advice. Pharm. Res. 14 969-975.
-
(1997)
Pharm. Res.
, vol.14
, pp. 969-975
-
-
Carpenter, J.F.1
Pikal, M.J.2
Chang, B.S.3
Randolph, T.W.4
-
18
-
-
68949085125
-
Mechanisms of protein stabilization in the solid state
-
L.Q. Chang and M.J. Pikal (2009) Mechanisms of protein stabilization in the solid state. J. Pharm. Sci. 98 2886-2908.
-
(2009)
J. Pharm. Sci.
, vol.98
, pp. 2886-2908
-
-
Chang, L.Q.1
Pikal, M.J.2
-
19
-
-
4644231090
-
Biopharmaceutic classification system: A scientific framework for pharmacokinetic optimization in drug research
-
M.V.S. Varma, S. Khandavilli, Y. Ashokraj, A. Jain, A. Dhanikula, A. Sood, et al. (2004) Biopharmaceutic classification system: A scientific framework for pharmacokinetic optimization in drug research. Curr. Drug Metab. 5 375-388.
-
(2004)
Curr. Drug Metab.
, vol.5
, pp. 375-388
-
-
Varma, M.V.S.1
Khandavilli, S.2
Ashokraj, Y.3
Jain, A.4
Dhanikula, A.5
Sood, A.6
-
20
-
-
33747795904
-
Disease, destination, dose and delivery aspects of ciclosporin: The state of the art
-
J.L. Italia, V. Bhardwaj and M.N. Kumar (2006) Disease, destination, dose and delivery aspects of ciclosporin: The state of the art. Drug Discov. Today 11 846-854.
-
(2006)
Drug Discov. Today
, vol.11
, pp. 846-854
-
-
Italia, J.L.1
Bhardwaj, V.2
Kumar, M.N.3
-
21
-
-
34547894266
-
Advanced delivery of ciclosporin A: Present state and perspective
-
H. Liu, Y. Wang and S. Li (2007) Advanced delivery of ciclosporin A: Present state and perspective. Expert Opin. Drug Deliv. 4 349-358.
-
(2007)
Expert Opin. Drug Deliv.
, vol.4
, pp. 349-358
-
-
Liu, H.1
Wang, Y.2
Li, S.3
-
22
-
-
71549161443
-
Inhaled insulin-intrapulmonary, intranasal, and other routes of administration: Mechanisms of action
-
R.I. Henkin (2010) Inhaled insulin-intrapulmonary, intranasal, and other routes of administration: Mechanisms of action. Nutrition 26 33-39.
-
(2010)
Nutrition
, vol.26
, pp. 33-39
-
-
Henkin, R.I.1
-
24
-
-
33747884001
-
Biodegradable nanoparticles loaded with insulin–phospholipid complex for oral delivery: Preparation, in vitro characterization and in vivo evaluation
-
F. Cui, K. Shi, L. Zhang, A. Tao and Y. Kawashima (2006) Biodegradable nanoparticles loaded with insulin–phospholipid complex for oral delivery: Preparation, in vitro characterization and in vivo evaluation. J. Control. Release 114 242-250.
-
(2006)
J. Control. Release
, vol.114
, pp. 242-250
-
-
Cui, F.1
Shi, K.2
Zhang, L.3
Tao, A.4
Kawashima, Y.5
-
25
-
-
33846543799
-
Oral delivery of insulin associated to polymeric nanoparticles in diabetic rats
-
C. Damge, P. Maincent and N. Ubrich (2007) Oral delivery of insulin associated to polymeric nanoparticles in diabetic rats. J. Control. Release 117 163-170.
-
(2007)
J. Control. Release
, vol.117
, pp. 163-170
-
-
Damge, C.1
Maincent, P.2
Ubrich, N.3
-
26
-
-
35549012407
-
Oral bioavailability of insulin contained in polysaccharide nanoparticles
-
B. Sarmento, A. Ribeiro, F. Veiga, D. Ferreira and R. Neufeld (2007) Oral bioavailability of insulin contained in polysaccharide nanoparticles. Biomacromolecules 8 3054-3060.
-
(2007)
Biomacromolecules
, vol.8
, pp. 3054-3060
-
-
Sarmento, B.1
Ribeiro, A.2
Veiga, F.3
Ferreira, D.4
Neufeld, R.5
-
27
-
-
77957285711
-
Microemulsions for oral delivery of insulin: Design, development and evaluation in streptozotocin induced diabetic rats
-
G. Sharma, K. Wilson, C.F. van der Walle, N. Sattar, J.R. Petrie and M.N. Ravi Kumar (2010) Microemulsions for oral delivery of insulin: Design, development and evaluation in streptozotocin induced diabetic rats. Eur. J. Pharm. Biopharm. 76 159-169.
-
(2010)
Eur. J. Pharm. Biopharm.
, vol.76
, pp. 159-169
-
-
Sharma, G.1
Wilson, K.2
van der Walle, C.F.3
Sattar, N.4
Petrie, J.R.5
Ravi Kumar, M.N.6
-
28
-
-
77954247722
-
Nasal and rectal delivery of insulin with chitosan and N-trimethyl chitosan chloride
-
L.H. du Plessis, A.F. Kotze and H.E. Junginger (2010) Nasal and rectal delivery of insulin with chitosan and N-trimethyl chitosan chloride. Drug Deliv. 17 399-407.
-
(2010)
Drug Deliv.
, vol.17
, pp. 399-407
-
-
du Plessis, L.H.1
Kotze, A.F.2
Junginger, H.E.3
-
29
-
-
34548331327
-
Comparison of oral insulin spray and subcutaneous regular insulin at mealtime in type 1 diabetes
-
J. Guevara-Aguirre, M. Guevara-Aguirre, J. Saavedra, G. Bernstein and A.L. Rosenbloom (2007) Comparison of oral insulin spray and subcutaneous regular insulin at mealtime in type 1 diabetes. Diabetes Technol. Ther. 9 372-376.
-
(2007)
Diabetes Technol. Ther.
, vol.9
, pp. 372-376
-
-
Guevara-Aguirre, J.1
Guevara-Aguirre, M.2
Saavedra, J.3
Bernstein, G.4
Rosenbloom, A.L.5
-
30
-
-
38349139874
-
Engineering biodegradable polyester particles with specific drug targeting and drug release properties
-
F. Mohamed and C.F. van der Walle (2008) Engineering biodegradable polyester particles with specific drug targeting and drug release properties. J. Pharm. Sci. 97 71-87.
-
(2008)
J. Pharm. Sci.
, vol.97
, pp. 71-87
-
-
Mohamed, F.1
van der Walle, C.F.2
-
32
-
-
72149125853
-
Sustained release hGH microsphere formulation produced by a novel supercritical fluid technology: In vivo studies
-
F. Jordan, A. Naylor, C.A. Kelly, S.M. Howdle, A. Lewis and L. Illum (2010) Sustained release hGH microsphere formulation produced by a novel supercritical fluid technology: In vivo studies. J. Control. Release 141 153-160.
-
(2010)
J. Control. Release
, vol.141
, pp. 153-160
-
-
Jordan, F.1
Naylor, A.2
Kelly, C.A.3
Howdle, S.M.4
Lewis, A.5
Illum, L.6
-
33
-
-
62949222418
-
A freeze-dried formulation of bacteriophage encapsulated in biodegradable microspheres
-
U. Puapermpoonsiri, J. Spencer and C.F. van der Walle (2009) A freeze-dried formulation of bacteriophage encapsulated in biodegradable microspheres. Eur. J. Pharm. Biopharm. 72 26-33.
-
(2009)
Eur. J. Pharm. Biopharm.
, vol.72
, pp. 26-33
-
-
Puapermpoonsiri, U.1
Spencer, J.2
van der Walle, C.F.3
-
34
-
-
0026610881
-
Humanization of an anti-p185HER2 antibody for human cancer therapy
-
P. Carter, L. Presta, C.M. Gorman, J.B. Ridgway, D. Henner, W.L. Wong, et al. (1992) Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc. Natl. Acad. Sci. U.S.A. 89 4285-4289.
-
(1992)
Proc. Natl. Acad. Sci. U.S.A.
, vol.89
, pp. 4285-4289
-
-
Carter, P.1
Presta, L.2
Gorman, C.M.3
Ridgway, J.B.4
Henner, D.5
Wong, W.L.6
-
35
-
-
77949772551
-
Encoding multiple unnatural amino acids via evolution of a quadruplet-decoding ribosome
-
H. Neumann, K. Wang, L. Davis, M. Garcia-Alai and J.W. Chin (2010) Encoding multiple unnatural amino acids via evolution of a quadruplet-decoding ribosome. Nature 464 441-444.
-
(2010)
Nature
, vol.464
, pp. 441-444
-
-
Neumann, H.1
Wang, K.2
Davis, L.3
Garcia-Alai, M.4
Chin, J.W.5
-
36
-
-
77955351179
-
Isolation of recombinant proteins from culture broth by co-precipitation with an amino acid carrier to form stable dry powders
-
B.D. Moore, J. Deere, R. Edrada-Ebel, A. Ingram and C.F. van der Walle (2010) Isolation of recombinant proteins from culture broth by co-precipitation with an amino acid carrier to form stable dry powders. Biotechnol. Bioeng. 106 764-773.
-
(2010)
Biotechnol. Bioeng.
, vol.106
, pp. 764-773
-
-
Moore, B.D.1
Deere, J.2
Edrada-Ebel, R.3
Ingram, A.4
van der Walle, C.F.5
-
37
-
-
0036593951
-
Preclinical safety evaluation of biotechnology-derived pharmaceuticals
-
J.A. Cavagnaro (2002) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Nat. Rev. Drug Discov. 1 469-475.
-
(2002)
Nat. Rev. Drug Discov.
, vol.1
, pp. 469-475
-
-
Cavagnaro, J.A.1
-
38
-
-
33748416499
-
Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412
-
G. Suntharalingam, M.R. Perry, S. Ward, S.J. Brett, A. Castello-Cortes, M.D. Brunner, et al. (2006) Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355 1018-1028.
-
(2006)
N. Engl. J. Med.
, vol.355
, pp. 1018-1028
-
-
Suntharalingam, G.1
Perry, M.R.2
Ward, S.3
Brett, S.J.4
Castello-Cortes, A.5
Brunner, M.D.6
-
39
-
-
77956304908
-
Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells
-
D. Eastwood, L. Findlay, S. Poole, C. Bird, M. Wadhwa, M. Moore, et al. (2010) Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells. Br. J. Pharmacol. 161 512-526.
-
(2010)
Br. J. Pharmacol.
, vol.161
, pp. 512-526
-
-
Eastwood, D.1
Findlay, L.2
Poole, S.3
Bird, C.4
Wadhwa, M.5
Moore, M.6
-
40
-
-
0033544305
-
Historical aspects of botulinum toxin: Justinus Kerner (1786–1862) and the “sausage poison”
-
F.J. Erbguth and M. Naumann (1999) Historical aspects of botulinum toxin: Justinus Kerner (1786–1862) and the “sausage poison”. Neurology 53 1850-1853.
-
(1999)
Neurology
, vol.53
, pp. 1850-1853
-
-
Erbguth, F.J.1
Naumann, M.2
-
41
-
-
22544464745
-
Pharmacology and immunology of botulinum neurotoxins
-
K.R. Aoki (2005) Pharmacology and immunology of botulinum neurotoxins. Int. Ophthalmol. Clin. 45 25-37.
-
(2005)
Int. Ophthalmol. Clin.
, vol.45
, pp. 25-37
-
-
Aoki, K.R.1
-
42
-
-
0036890997
-
Immune responses to therapeutic proteins in humans – clinical significance, assessment and prediction
-
E. Koren, L.A. Zuckerman and A.R. Mire-Sluis (2002) Immune responses to therapeutic proteins in humans – clinical significance, assessment and prediction. Curr. Pharm. Biotechnol. 3 349-360.
-
(2002)
Curr. Pharm. Biotechnol.
, vol.3
, pp. 349-360
-
-
Koren, E.1
Zuckerman, L.A.2
Mire-Sluis, A.R.3
-
43
-
-
3843149585
-
Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans
-
P.J. Bugelski and G. Treacy (2004) Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. Curr. Opin. Mol. Ther. 6 10-16.
-
(2004)
Curr. Opin. Mol. Ther.
, vol.6
, pp. 10-16
-
-
Bugelski, P.J.1
Treacy, G.2
-
44
-
-
23644446012
-
Guidelines from the International Conference on Harmonization (ICH)
-
S.K. Branch (2005) Guidelines from the International Conference on Harmonization (ICH). J. Pharm. Biomed. Anal. 38 798-805.
-
(2005)
J. Pharm. Biomed. Anal.
, vol.38
, pp. 798-805
-
-
Branch, S.K.1
-
45
-
-
8444226372
-
The Impact of Implementation of ICH Guidelines in Non-ICH Countries –
-
1–30
-
World Health Organization. The Impact of Implementation of ICH Guidelines in Non-ICH Countries – Regulatory Support Series No. 9, (2002), pp. 1–30.
-
(2002)
Regulatory Support Series
, Issue.9
-
-
-
47
-
-
84882524588
-
CMC issues and regulatory requirements for biosimilars
-
B.-L. Chen (2009) CMC issues and regulatory requirements for biosimilars. Trends in Bio/Pharmaceutical Industry 5 19-26.
-
(2009)
Trends in Bio/Pharmaceutical Industry
, vol.5
, pp. 19-26
-
-
Chen, B.-L.1
-
48
-
-
33745096842
-
Eprex-associated pure red cell aplasia and leachates
-
H. Schellekens and W. Jiskoot (2006) Eprex-associated pure red cell aplasia and leachates. Nat. Biotechnol. 24 613-614.
-
(2006)
Nat. Biotechnol.
, vol.24
, pp. 613-614
-
-
Schellekens, H.1
Jiskoot, W.2
-
49
-
-
33749839199
-
Reactions to Eprex's adverse events
-
B. Sharma, M.H. Ryan and K. Boven (2006) Reactions to Eprex's adverse events. Nat. Biotechnol. 24 1199-1200.
-
(2006)
Nat. Biotechnol.
, vol.24
, pp. 1199-1200
-
-
Sharma, B.1
Ryan, M.H.2
Boven, K.3
-
50
-
-
53549097062
-
Clinical comparisons of botulinum neurotoxin formulations
-
A. Brashear (2008) Clinical comparisons of botulinum neurotoxin formulations. Neurologist 14 289-298.
-
(2008)
Neurologist
, vol.14
, pp. 289-298
-
-
Brashear, A.1
-
51
-
-
60149106150
-
Quality by design for biopharmaceuticals
-
A.S. Rathore and H. Winkle (2009) Quality by design for biopharmaceuticals. Nat. Biotechnol. 27 26-34.
-
(2009)
Nat. Biotechnol.
, vol.27
, pp. 26-34
-
-
Rathore, A.S.1
Winkle, H.2
-
52
-
-
84882543406
-
Quality by design (QbD), biopharmaceutical manufacture
-
M.C. Flickinger (Ed.), Oxford, UK: Wiley-Blackwell
-
R.B. Shah, J.T. Park, E.K. Read, M.A. Khan and K. Brorson (2010) Quality by design (QbD), biopharmaceutical manufacture. M.C. Flickinger (Ed.) Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology Oxford, UK: Wiley-Blackwell 1-36.
-
(2010)
Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology
, pp. 1-36
-
-
Shah, R.B.1
Park, J.T.2
Read, E.K.3
Khan, M.A.4
Brorson, K.5
|