-
1
-
-
0242423263
-
Methods in Molecular Medicine
-
Ed Findeis MA. Humana Press Inc., Totowa, NJ
-
Allison SD, Anchordoquy TJ (2001) In Methods in Molecular Medicine. Ed Findeis MA. Humana Press Inc., Totowa, NJ; Vol. 65: 225-252.
-
(2001)
, vol.65
, pp. 225-252
-
-
Allison, S.D.1
Anchordoquy, T.J.2
-
3
-
-
0030586740
-
Arch. Biochem. Biophys
-
Anchordoquy TJ, Carpenter JF (1996) Arch. Biochem. Biophys.; 332: 231-236.
-
(1996)
, vol.332
, pp. 231-236
-
-
Anchordoquy, T.J.1
Carpenter, J.F.2
-
5
-
-
84889268978
-
Freeze Drying/Lyophilization of Pharmaceutical and Biological Products
-
Eds Rey L, May JC. Marcel Dekker, New York; second edition
-
Bindschaedler E (2004) In Freeze Drying/Lyophilization of Pharmaceutical and Biological Products. Eds Rey L, May JC. Marcel Dekker, New York; second edition: 535-574.
-
(2004)
, pp. 535-574
-
-
Bindschaedler, E.1
-
7
-
-
0034854492
-
Pharm. Res
-
Breen ED, Curley JG, Overcashier DE, Hsu CC, Shire SJ (2001) Pharm. Res.; 18: 1345-1353.
-
(2001)
, vol.18
, pp. 1345-1353
-
-
Breen, E.D.1
Curley, J.G.2
Overcashier, D.E.3
Hsu, C.C.4
Shire, S.J.5
-
10
-
-
0032963287
-
Crit. Rev. Ther. Drug Car. Syst
-
Burke CJ, Hfu T-A, Volkin DB (1999) Crit. Rev. Ther. Drug Car. Syst.; 16(1): 1-80.
-
(1999)
, vol.16
, Issue.1
, pp. 1-80
-
-
Burke, C.J.1
Hfu, T.-A.2
Volkin, D.B.3
-
11
-
-
0012310214
-
Good Pharmaceutical Freeze Drying Practice
-
Interpharm/CRC Press, Boca Raton, FL, USA
-
Cameron P, Murgatroyd K (Eds)(1997) Good Pharmaceutical Freeze Drying Practice. Interpharm/CRC Press, Boca Raton, FL, USA.
-
(1997)
-
-
Cameron, P.1
Murgatroyd, K.2
-
12
-
-
0343918730
-
Animal Cell Biotechnology Eds Spier RE, Griffiths BJ
-
Academic Press, London
-
Cammack KA, Adams GDJ (1985) In Animal Cell Biotechnology Eds Spier RE, Griffiths BJ. Academic Press, London; Vol. 2: 251-288.
-
(1985)
, vol.2
, pp. 251-288
-
-
Cammack, K.A.1
Adams, G.D.J.2
-
16
-
-
0027163083
-
J. Parenter. Sci. Technol
-
Connelly JP, Welch JV (1993) J. Parenter. Sci. Technol.; 47: 70-75.
-
(1993)
, vol.47
, pp. 70-75
-
-
Connelly, J.P.1
Welch, J.V.2
-
18
-
-
0038545605
-
Thermochim. Acta
-
Danley RL (2003) Thermochim. Acta; 402: 91-98.
-
(2003)
, vol.402
, pp. 91-98
-
-
Danley, R.L.1
-
19
-
-
0036909496
-
Am. Pharm. Rev
-
Davis SS (2002) Am. Pharm. Rev.; 5: 29-36.
-
(2002)
, vol.5
, pp. 29-36
-
-
Davis, S.S.1
-
21
-
-
0036407029
-
Annu. Rev. Biomed. Eng
-
Edwards DA, Dunbar C (2002) Annu. Rev. Biomed. Eng.; 4: 93-107.
-
(2002)
, vol.4
, pp. 93-107
-
-
Edwards, D.A.1
Dunbar, C.2
-
22
-
-
0141678818
-
Pharm. Res
-
Eriksson JHC, Hinrich WLJ, de Jong GJ, Somsen GW, Frijlink HW (2003) Pharm. Res.; 20: 1437-1443.
-
(2003)
, vol.20
, pp. 1437-1443
-
-
Eriksson, J.H.C.1
Hinrich, W.L.J.2
de Jong, G.J.3
Somsen, G.W.4
Frijlink, H.W.5
-
23
-
-
0012757295
-
Guide to Inspections of Lyophilization of Parenterals
-
FDA, available at
-
FDA (1998) Guide to Inspections of Lyophilization of Parenterals, available at http://www.fda.gov/ora/inspect_ref/igs/lyophi.html
-
(1998)
-
-
-
24
-
-
21244462394
-
J. Clin. Endocrinol. Metab
-
Fineberg SE, Kawabata T, Finco-Kent D, Liu C, Krasner A (2005) J. Clin. Endocrinol. Metab.; 90: 3287-3294.
-
(2005)
, vol.90
, pp. 3287-3294
-
-
Fineberg, S.E.1
Kawabata, T.2
Finco-Kent, D.3
Liu, C.4
Krasner, A.5
-
26
-
-
0028235235
-
Biologicals
-
Ford AW, Dawson PJ (1994) Biologicals; 22: 191-187.
-
(1994)
, vol.22
, pp. 191-187
-
-
Ford, A.W.1
Dawson, P.J.2
-
27
-
-
0001844127
-
CryoLetters
-
Franks F (1990) CryoLetters; 11: 93-110.
-
(1990)
, vol.11
, pp. 93-110
-
-
Franks, F.1
-
29
-
-
84889374867
-
Appl. Microbiology
-
Grieff D, Rightseal WA (1968) Appl. Microbiology; 16: 835-840.
-
(1968)
, vol.16
, pp. 835-840
-
-
Grieff, D.1
Rightseal, W.A.2
-
30
-
-
84889277334
-
Freeze Drying/lLyophilization of Pharmaceutical and Biological Products
-
Eds Rey L, May JC. Marcel Dekker, New York; second edition
-
Hora MS, Wolfe SN (2004) In Freeze Drying/lLyophilization of Pharmaceutical and Biological Products. Eds Rey L, May JC. Marcel Dekker, New York; second edition: 309-324.
-
(2004)
, pp. 309-324
-
-
Hora, M.S.1
Wolfe, S.N.2
-
32
-
-
0036861462
-
PDA J. Pharm. Sci. Tech
-
Jenke D (2002) PDA J. Pharm. Sci. Tech.; 56: 332-371.
-
(2002)
, vol.56
, pp. 332-371
-
-
Jenke, D.1
-
33
-
-
0003936989
-
Lyophilization: Introduction and Basic Principles
-
Interpharm Press. Denver, Colorado, USA
-
Jennings TA (1999) Lyophilization: Introduction and Basic Principles. Interpharm Press. Denver, Colorado, USA; 165-252.
-
(1999)
, pp. 165-252
-
-
Jennings, T.A.1
-
34
-
-
84889486467
-
Eur. J. Pharm. Biopharm
-
Jiang S, Nail SL (1998) Eur. J. Pharm. Biopharm.; 45: 245-257.
-
(1998)
, vol.45
, pp. 245-257
-
-
Jiang, S.1
Nail, S.L.2
-
35
-
-
21644437615
-
Pharm. Res
-
Jovanovic N, Bouchard A, Hofland GW, Witkamp GJ, Crommelin DJA, Jiskoot W (2004) Pharm. Res.; 21: 1955-1969.
-
(2004)
, vol.21
, pp. 1955-1969
-
-
Jovanovic, N.1
Bouchard, A.2
Hofland, G.W.3
Witkamp, G.J.4
Crommelin, D.J.A.5
Jiskoot, W.6
-
36
-
-
0012138671
-
Eur. J Parenteral Sci
-
Kett V (2001) Eur. J Parenteral Sci.; 6: 95-99.
-
(2001)
, vol.6
, pp. 95-99
-
-
Kett, V.1
-
38
-
-
1942487690
-
Diabetic Medicine
-
Kidron M, Dinh S, Menachem Y et al. (2004) Diabetic Medicine; 21: 354-357.
-
(2004)
, vol.21
, pp. 354-357
-
-
Kidron, M.1
Dinh, S.2
Menachem, Y.3
-
39
-
-
0032945323
-
J. Pharm. Sci
-
Lai MC, Topp EM (1999) J. Pharm. Sci.; 88: 489-500.
-
(1999)
, vol.88
, pp. 489-500
-
-
Lai, M.C.1
Topp, E.M.2
-
41
-
-
0002459877
-
Wat. Sci. Rev
-
Levine H, Slade L (1988) Wat. Sci. Rev.; 3: 79-185.
-
(1988)
, vol.3
, pp. 79-185
-
-
Levine, H.1
Slade, L.2
-
43
-
-
0029781099
-
J. Pharm. Sci
-
Li S, Patapoff TW, Overcashier D, Hsu C, Nguyen TH, Borchardt RT (1996) J. Pharm. Sci.; 85: 873-877.
-
(1996)
, vol.85
, pp. 873-877
-
-
Li, S.1
Patapoff, T.W.2
Overcashier, D.3
Hsu, C.4
Nguyen, T.H.5
Borchardt, R.T.6
-
44
-
-
0036327651
-
PDA J. Pharm. Sci. Technol
-
Lin TP, Hsu CC (2002) PDA J. Pharm. Sci. Technol.; 56(4): 196-205.
-
(2002)
, vol.56
, Issue.4
, pp. 196-205
-
-
Lin, T.P.1
Hsu, C.C.2
-
45
-
-
0034331056
-
Curr. Biopharm. Biotechnol
-
Maa Y, Prestrelski SJ (2000) Curr. Biopharm. Biotechnol.; 1: 283-302.
-
(2000)
, vol.1
, pp. 283-302
-
-
Maa, Y.1
Prestrelski, S.J.2
-
47
-
-
3042692494
-
J. Pharm. Sci
-
Maa Y-F, Ameri M, Shu C, Payne LG, Chen D (2004) J. Pharm. Sci.; 93: 1912-1923.
-
(2004)
, vol.93
, pp. 1912-1923
-
-
Maa, Y.-F.1
Ameri, M.2
Shu, C.3
Payne, L.G.4
Chen, D.5
-
48
-
-
0012240094
-
Biodynamics
-
MacKenzie AP (1964) Biodynamics; 9: 223-231.
-
(1964)
, vol.9
, pp. 223-231
-
-
MacKenzie, A.P.1
-
52
-
-
84889351971
-
-
Medicines Control Agency, MCA, Rules and Guidance for Pharmaceutical Manufacturers and Distributors. HMSO, London
-
Medicines Control Agency, MCA (2002) Rules and Guidance for Pharmaceutical Manufacturers and Distributors. HMSO, London.
-
(2002)
-
-
-
54
-
-
34247179440
-
Pharmaceutical Isolators: A Guide to Their Application and Design
-
Pharmaceutical Press, London
-
Midcalf B, Phillips MW, Neiger JS, Coles TJ (Eds) (2004) Pharmaceutical Isolators: A Guide to Their Application and Design. Pharmaceutical Press, London.
-
(2004)
-
-
Midcalf, B.1
Phillips, M.W.2
Neiger, J.S.3
Coles, T.J.4
-
57
-
-
0033858621
-
Eur. J Pharm. Sci
-
Moshashaee S, Bisrat M, Forbes RT, Nyqvist H, York P (2000) Eur. J Pharm. Sci.; 11: 239-245.
-
(2000)
, vol.11
, pp. 239-245
-
-
Moshashaee, S.1
Bisrat, M.2
Forbes, R.T.3
Nyqvist, H.4
York, P.5
-
58
-
-
84889319318
-
Eur. J Parenteral Sci
-
Murgatroyd K (2001) Eur. J Parenteral Sci.; 6:(1) 21-26.
-
(2001)
, vol.6
, Issue.1
, pp. 21-26
-
-
Murgatroyd, K.1
-
59
-
-
3242805661
-
Good Pharamaceutical Freeze Drying Practice
-
Eds Cameron P, Murgatroyd K. Interpharm/CRC Press, Boca Raton, FL, USA
-
Murgatroyd K (1997) In Good Pharamaceutical Freeze Drying Practice. Eds Cameron P, Murgatroyd K. Interpharm/CRC Press, Boca Raton, FL, USA; 1-58.
-
(1997)
, pp. 1-58
-
-
Murgatroyd, K.1
-
60
-
-
0027272126
-
J. Parent. Sci. Technol
-
Nena S, Avis KE (1992) J. Parent. Sci. Technol.; 47: 76-83.
-
(1992)
, vol.47
, pp. 76-83
-
-
Nena, S.1
Avis, K.E.2
-
61
-
-
0038033992
-
Freeze Drying
-
VCH Wiley Press, Weinheim
-
Oetjen GW (1999) Freeze Drying. VCH Wiley Press, Weinheim.
-
(1999)
-
-
Oetjen, G.W.1
-
62
-
-
84889426464
-
Specification and Validation of Freeze Dryers
-
Parenteral Society, Technical Monograph No 9, The Parenteral Society, Swindon, UK
-
Parenteral Society (1997) Specification and Validation of Freeze Dryers, Technical Monograph No 9, The Parenteral Society, Swindon, UK.
-
(1997)
-
-
-
64
-
-
0035164507
-
ASAIO J
-
Petersen J, Jani A (2001) ASAIO J. 47: 608-610.
-
(2001)
, vol.47
, pp. 608-610
-
-
Petersen, J.1
Jani, A.2
-
65
-
-
0037161401
-
Macromolecules
-
Pijpers TFJ, Mathot VBF, Goderis B, Scherrenberg RL, van der Vegte EW (2002) Macromolecules; 35: 3601-3613.
-
(2002)
, vol.35
, pp. 3601-3613
-
-
Pijpers, T.F.J.1
Mathot, V.B.F.2
Goderis, B.3
Scherrenberg, R.L.4
van der Vegte, E.W.5
-
67
-
-
0001381253
-
Dev. Biol. Stand
-
Discussion, 74, 147-179
-
Pikal MJ, Shah S (1992) Dev. Biol. Stand.; 74: 165-177. Discussion, 74: 147-179.
-
(1992)
, vol.74
, pp. 165-177
-
-
Pikal, M.J.1
Shah, S.2
-
69
-
-
3042835497
-
Biodynamica
-
Rey LR (1961) Biodynamica; 8: 241-260.
-
(1961)
, vol.8
, pp. 241-260
-
-
Rey, L.R.1
-
70
-
-
0032611494
-
Dev. Biol. Stand
-
Robinson CJ (1999) Dev. Biol. Stand.; 97: 21-27.
-
(1999)
, vol.97
, pp. 21-27
-
-
Robinson, C.J.1
-
71
-
-
84889393560
-
-
Handbook of Pharmaceutical Excipients Pharmaceutical Press/American Pharmaceutical Association, Grayslake, USA; fourth edition
-
Rowe RC, Sheskey PJ, Weller PJ (Eds) (2005) Handbook of Pharmaceutical Excipients Pharmaceutical Press/American Pharmaceutical Association, Grayslake, USA; fourth edition.
-
(2005)
-
-
Rowe, R.C.1
Sheskey, P.J.2
Weller, P.J.3
-
72
-
-
28244434046
-
Cryoletters
-
Rowe T (2005) Cryoletters; 26: 297-304.
-
(2005)
, vol.26
, pp. 297-304
-
-
Rowe, T.1
-
74
-
-
0031786396
-
Biologicals
-
Savage M, Torres J, Franks L, Masecar B, Hotta JA (1998) Biologicals; 26: 119-224.
-
(1998)
, vol.26
, pp. 119-224
-
-
Savage, M.1
Torres, J.2
Franks, L.3
Masecar, B.4
Hotta, J.A.5
-
75
-
-
0020972904
-
Dev. Biol. Stand
-
Scheiermann N, Kuwert EK (1983) Dev. Biol. Stand.; 54: 347-355.
-
(1983)
, vol.54
, pp. 347-355
-
-
Scheiermann, N.1
Kuwert, E.K.2
-
76
-
-
79952240232
-
Freeze Drying/Lyophilization of Pharmaceutical and Biological Products
-
Eds Rey L, May JC. Marcel Dekker, New York; second edition
-
Searles JA (2004) In Freeze Drying/Lyophilization of Pharmaceutical and Biological Products. Eds Rey L, May JC. Marcel Dekker, New York; second edition: 109-145.
-
(2004)
, pp. 109-145
-
-
Searles, J.A.1
-
80
-
-
84889353038
-
-
United States Food and Drug Administration, Guideline on Sterile Drug Products Produced by Aseptic Processing
-
United States Food and Drug Administration (1987) Guideline on Sterile Drug Products Produced by Aseptic Processing.
-
(1987)
-
-
-
81
-
-
0004058322
-
Guide to Inspections of Lyophilization of Parenterals
-
United States Food and Drug Administration, at
-
United States Food and Drug Administration. Guide to Inspections of Lyophilization of Parenterals at http://www.fda.gov/ora/inspect_ref/igs/lyophi.html
-
-
-
-
82
-
-
0034255393
-
Int. J. Pharm
-
Wang W (2000) Int. J. Pharm.; 203: 1-60.
-
(2000)
, vol.203
, pp. 1-60
-
-
Wang, W.1
-
83
-
-
0003494595
-
Good Manufacturing Practices for Pharmaceutical Products: Main Principles
-
WHO
-
WHO (2003) Good Manufacturing Practices for Pharmaceutical Products: Main Principles, WHO Tech. Report Ser.; 908: 37-89.
-
(2003)
WHO Tech. Report Ser
, vol.908
, pp. 37-89
-
-
-
84
-
-
0004981769
-
Freeze Drying/Lyophilization of Pharmaceutical and Biological Products
-
Eds Rey L, May JC Marcel Dekker, New York
-
Willemer H (1999) In Freeze Drying/Lyophilization of Pharmaceutical and Biological Products. Eds Rey L, May JC Marcel Dekker, New York; 79-122.
-
(1999)
, pp. 79-122
-
-
Willemer, H.1
|