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Volumn , Issue , 2004, Pages 385-424

Freeze-drying of biological standards

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EID: 84925568500     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (9)

References (33)
  • 1
    • 0016167667 scopus 로고
    • Procedure used for the production of biological standards and reference preparations
    • International biological standards and reference preparations II
    • Campbell PJ. International biological standards and reference preparations II. Procedure used for the production of biological standards and reference preparations. J Biol Stand 2:255-267, 1974.
    • (1974) J Biol Stand , vol.2 , pp. 255-267
    • Campbell, P.J.1
  • 2
    • 0012789066 scopus 로고    scopus 로고
    • The preparation of international biological standards
    • Phillips P. The preparation of international biological standards. Fresenius J Anal Chem 360:473-75, 1998.
    • (1998) Fresenius J Anal Chem , vol.360 , pp. 473-475
    • Phillips, P.1
  • 3
    • 0042750765 scopus 로고    scopus 로고
    • WHO Expert Committee on Biological Standards 50th Report. WHO Technical Report Series 904, 2002
    • (2002) WHO Technical Report Series , pp. 904
  • 4
    • 0033816633 scopus 로고    scopus 로고
    • Reference reagents for prostate-specific antigen (Psa): Establishment of the first international standards for free psa and psa (90:10)
    • Rafiferty B, Rigsby P, Rose M, Stamey T, Gaines Das R. Reference reagents for prostate-specific antigen (PSA): establishment of the first international standards for free PSA and PSA (90:10). Clin Chem 46(9): 1310-1317, 2000.
    • (2000) Clin Chem , vol.46 , Issue.9 , pp. 1310-1317
    • Rafiferty, B.1    Rigsby, P.2    Rose, M.3    Stamey, T.4    Gaines Das, R.5
  • 5
    • 0034781696 scopus 로고    scopus 로고
    • Calibration of replacement first international standard and ep biological reference preparation for diphtheria toxoid adsorbed
    • Sesardic D, Wisnes R, Rigsby P, Gaines-Das R. Calibration of replacement first international standard and EP biological reference preparation for diphtheria toxoid adsorbed. Biologicals 29:107-112, 2001.
    • (2001) Biologicals , vol.29 , pp. 107-112
    • Sesardic, D.1    Wisnes, R.2    Rigsby, P.3    Gaines-Das, R.4
  • 6
    • 0035240915 scopus 로고    scopus 로고
    • An international collaborative study to establish who international standard for hepatitis b virus dna nucleic acid amplification techniques
    • Saldanha J, Gerlich W, Lelie N, Dawson P, Heerman K, Heath A. An international collaborative study to establish WHO international standard for Hepatitis B virus DNA nucleic acid amplification techniques. Vox sang 80:63-71, 2001.
    • (2001) Vox Sang , vol.80 , pp. 63-71
    • Saldanha, J.1    Gerlich, W.2    Lelie, N.3    Dawson, P.4    Heerman, K.5    Heath, A.6
  • 7
    • 0034747902 scopus 로고    scopus 로고
    • Multicentre collaborative study to calibrate igf-ii by bioassay and immunoassay: Establishment of the first who reference reagent
    • Rafferty B, Rigsby P, Gaines Das RE. Multicentre collaborative study to calibrate IGF-II by bioassay and immunoassay: establishment of the First WHO Reference Reagent. Growth Hormones & IGF Research 11:18-23, 2001.
    • (2001) Growth Hormones & IGF Research , vol.11 , pp. 18-23
    • Rafferty, B.1    Rigsby, P.2    Gaines Das, R.E.3
  • 8
    • 0035545735 scopus 로고    scopus 로고
    • International standards for hepatocyte growth factor/scatter factor: Initial assessment of candidate materials and their evaluation by multicentre collaborative study
    • Rafferty B, Maille P, Rigsby P, Gaines Das RE, Robinson CJ. International standards for hepatocyte growth factor/scatter factor: initial assessment of candidate materials and their evaluation by multicentre collaborative study. J Immunol Methods 258:1-11, 2001.
    • (2001) J Immunol Methods , vol.258 , pp. 1-11
    • Rafferty, B.1    Maille, P.2    Rigsby, P.3    Gaines Das, R.E.4    Robinson, C.J.5
  • 9
    • 0034883289 scopus 로고    scopus 로고
    • First international standard for human leptin and first international standard for mouse leptin
    • Robinson CJ, Gaines Das R, Woolacott D. First international standard for human leptin and first international standard for mouse leptin. J Mol Endocrinol 27:69-76, 2001.
    • (2001) J Mol Endocrinol , vol.27 , pp. 69-76
    • Robinson, C.J.1    Gaines Das, R.2    Woolacott, D.3
  • 10
    • 0034900274 scopus 로고    scopus 로고
    • Multicentre collaborative study to calibrate salmon calcitonin by bioassay and hplc: Establishment of the third international standard
    • Rafferty B, Corran P, Bristow A. Multicentre collaborative study to calibrate salmon calcitonin by bioassay and HPLC: establishment of the Third International Standard. Bone 29(l):84-89, 2001.
    • (2001) Bone , vol.29 , Issue.1 , pp. 84-89
    • Rafferty, B.1    Corran, P.2    Bristow, A.3
  • 11
    • 0003680447 scopus 로고
    • WHO guidelines for the preparation, characterization and establishment of international and other standards and reference reagents for biological standardization. WHO Tech Rep Ser 800:181-214, 1990.
    • (1990) WHO Tech Rep Ser , vol.800 , pp. 181-214
  • 12
    • 0025870533 scopus 로고
    • The use of din glass ampoules to freeze-dry biological materials with a low residual moisture and oxygen content
    • Phillips PK, Dawson PJ, Delderfield A. The use of DIN glass ampoules to freeze-dry biological materials with a low residual moisture and oxygen content. Biologicals 19:219-221, 1991.
    • (1991) Biologicals , vol.19 , pp. 219-221
    • Phillips, P.K.1    Dawson, P.J.2    Delderfield, A.3
  • 13
    • 0026493533 scopus 로고
    • Measurement of final container residual moisture in freeze dried biological products
    • May JC, Wheeler RM, Elz N, DelGrons A. Measurement of final container residual moisture in freeze dried biological products. Dev Biol Stand 74:153-164, 1992.
    • (1992) Dev Biol Stand , vol.74 , pp. 153-164
    • May, J.C.1    Wheeler, R.M.2    Elz, N.3    DelGrons, A.4
  • 14
    • 0000308653 scopus 로고    scopus 로고
    • Guidelines for validation of the freeze drying process
    • Jennings TA. Guidelines for validation of the freeze drying process. J Validation Technol 3:386-391, 1997.
    • (1997) J Validation Technol , vol.3 , pp. 386-391
    • Jennings, T.A.1
  • 17
    • 0023919420 scopus 로고
    • Additives to biological substances iv. Lyophilization conditions in the preparation of international standards: An analysis by high performance liquid chromatography of the effects of secondary desiccation
    • Bristow AF, Dunn D, Tarelli E. Additives to biological substances IV. Lyophilization conditions in the preparation of International Standards: an analysis by high performance liquid chromatography of the effects of secondary desiccation. J Biol Stand 16:55-61, 1988.
    • (1988) J Biol Stand , vol.16 , pp. 55-61
    • Bristow, A.F.1    Dunn, D.2    Tarelli, E.3
  • 20
    • 0032077463 scopus 로고    scopus 로고
    • Effect of processing conditions on recovery of protein activity after freezing and freeze drying
    • Jiang S, Nail SL. Effect of processing conditions on recovery of protein activity after freezing and freeze drying. Eur J Pharm Biopharm 45:245-257, 1998.
    • (1998) Eur J Pharm Biopharm , vol.45 , pp. 245-257
    • Jiang, S.1    Nail, S.L.2
  • 21
    • 0030770631 scopus 로고    scopus 로고
    • Rational design of stable lyophilized product formulation theory and practice
    • Carpenter JF, Chang BS, Garzon-Rodrigues W, Randolph TW. Rational design of stable lyophilized product formulation theory and practice. Pharm Res 14:969-975, 1997.
    • (1997) Pharm Res , vol.14 , pp. 969-975
    • Carpenter, J.F.1    Chang, B.S.2    Garzon-Rodrigues, W.3    Randolph, T.W.4
  • 22
    • 0027471239 scopus 로고
    • The effect of carbohydrate additives in the freeze drying of alkaline phosphatase
    • Ford AW, Dawson PJ. The effect of carbohydrate additives in the freeze drying of alkaline phosphatase. J Pharm Pharmacol 45:86-93,1993.
    • (1993) J Pharm Pharmacol , vol.45 , pp. 86-93
    • Ford, A.W.1    Dawson, P.J.2
  • 23
    • 0034255393 scopus 로고    scopus 로고
    • Lyophilization and development of solid protein pharmaceuticals
    • Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 203:1-60, 2000.
    • (2000) Int J Pharm , vol.203 , pp. 1-60
    • Wang, W.1
  • 24
    • 0030965088 scopus 로고    scopus 로고
    • Use of sub ambient differential scanning calorimetry to monitor the frozen state behaviour of blends of excipients for freeze drying
    • Martini A, Kume S, Rivaldelo M, Arito R. Use of sub ambient differential scanning calorimetry to monitor the frozen state behaviour of blends of excipients for freeze drying. PDA J Pharm Sci Technol 51:62-67, 1997.
    • (1997) PDA J Pharm Sci Technol , vol.51 , pp. 62-67
    • Martini, A.1    Kume, S.2    Rivaldelo, M.3    Arito, R.4
  • 25
    • 0012138671 scopus 로고    scopus 로고
    • Modulated temperature differential scanning calorimetry and its application to freeze-drying
    • Kett V. Modulated temperature differential scanning calorimetry and its application to freeze-drying. Eur J Parenter Sci 6:95-99, 2001.
    • (2001) Eur J Parenter Sci , vol.6 , pp. 95-99
    • Kett, V.1
  • 26
    • 0035004725 scopus 로고    scopus 로고
    • Freeze dried preparations of some oligonucleotides
    • Jameel F, Amsberry KC, Pikal MJ. Freeze dried preparations of some oligonucleotides. Pharm Dev Technol 65:151-157, 2001.
    • (2001) Pharm Dev Technol , vol.65 , pp. 151-157
    • Jameel, F.1    Amsberry, K.C.2    Pikal, M.J.3
  • 27
    • 0013798991 scopus 로고
    • Lyophilisationof pharmaceuticals if. High sensitivity resistance bridge for low conductance measurements at eutectic temperatures
    • LachmanL, Deluca PP, Withnell R. Lyophilisation bof pharmaceuticals.High sensitivity resistance bridge for low conductance measurements at eutectic temperatures. J Pharm Sci 54:1342-1347, 1965.
    • (1965) J Pharm Sci , vol.54 , pp. 1342-1347
    • Lachman, L.1    Deluca, P.P.2    Withnell, R.3
  • 28
    • 0017591703 scopus 로고
    • Physicochemical basis for the freeze drying process
    • MacKenzie AP. Physicochemical basis for the freeze drying process. Dev Biol Stand 36:51-67, 1977.
    • (1977) Dev Biol Stand , vol.36 , pp. 51-67
    • MacKenzie, A.P.1
  • 29
    • 0028050373 scopus 로고
    • An improved microscope stage for direct observation of freezing and freeze drying
    • Nail SL, Mer LM, Proffitt C, Nail L. An improved microscope stage for direct observation of freezing and freeze drying. Pharm Res 11:1098-1100, 1994.
    • (1994) Pharm Res , vol.11 , pp. 1098-1100
    • Nail, S.L.1    Mer, L.M.2    Proffitt, C.3    Nail, L.4
  • 30
    • 77951956487 scopus 로고    scopus 로고
    • Freeze drying a review
    • Murgatroyd K, Freeze drying a review, Eur J Parenter Sci 6:21-25, 2001.
    • (2001) Eur J Parenter Sci , vol.6 , pp. 21-25
    • Murgatroyd, K.1
  • 31
    • 0017658328 scopus 로고
    • Predicted stability of biological standards and products
    • Kirkwood, TBL. Predicted stability of biological standards and products. Biometrics 33:736-742, 1977.
    • (1977) Biometrics , vol.33 , pp. 736-742
    • Kirkwood, T.B.L.1
  • 32
    • 0021704849 scopus 로고
    • Design and analysis of accelerated degradation tests for the stability of biological standards iii. Principles of design
    • Kirkwood, TBL, Design and analysis of accelerated degradation tests for the stability of biological standards III. Principles of design. J Biol, Stand 12:215-224, 1984.
    • (1984) J Biol, Stand , vol.12 , pp. 215-224
    • Kirkwood, T.1
  • 33
    • 0028235235 scopus 로고
    • Effect of type of container, storage temperature and humidity on the biological activity of freeze-dried alkaline phosphatase
    • Ford AW, Dawson PJ. Effect of type of container, storage temperature and humidity on the biological activity of freeze-dried alkaline phosphatase. Biologicals 22:191-197, 1994.
    • (1994) Biologicals , vol.22 , pp. 191-197
    • Ford, A.W.1    Dawson, P.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.