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Volumn 9, Issue 5, 2006, Pages

Alternative microbiological methods in the pharmaceutical industry: The need for a new microbiology curriculum

Author keywords

[No Author keywords available]

Indexed keywords

CAPILLARY ELECTROCHROMATOGRAPHY; CELL VIABILITY; DRUG INDUSTRY; FLOW CYTOMETRY; FLUORESCENCE RESONANCE ENERGY TRANSFER; FOOD AND DRUG ADMINISTRATION; GEL ELECTROPHORESIS; GENOME ANALYSIS; GOOD MANUFACTURING PRACTICE; HEALTH PRACTITIONER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; MEDICAL EDUCATION; MICROBIOLOGICAL EXAMINATION; POLYMERASE CHAIN REACTION; PROTEOMICS; QUALITY CONTROL; REVIEW;

EID: 55749116364     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (7)

References (14)
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    • May, M. Building a better biosensor. The Scientist. 100:36-38, 2004.
    • (2004) The Scientist , vol.100 , pp. 36-38
    • May, M.1
  • 2
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    • Opportunities for the Pharmaceutical Industry (Chapter 6)
    • ed. Miller M, Parenteral Drug Association, Bethesda, MD, pp
    • Sutton S.V.W. "Opportunities for the Pharmaceutical Industry (Chapter 6)" in Encyclopedia of Rapid Microbiological Methods, ed. Miller M., Parenteral Drug Association, Bethesda, MD, pp273-290, 2005.
    • (2005) Encyclopedia of Rapid Microbiological Methods , pp. 273-290
    • Sutton, S.V.W.1
  • 3
    • 55749085583 scopus 로고    scopus 로고
    • U.S. Pharmacopoeia 〈1223〉 Validation of Alternative Microbiological Methods. USP in Pharmacopoeial Forum, 31:1475- 1486, 2005.
    • U.S. Pharmacopoeia 〈1223〉 Validation of Alternative Microbiological Methods. USP in Pharmacopoeial Forum, 31:1475- 1486, 2005.
  • 4
    • 55749094965 scopus 로고    scopus 로고
    • European Pharmacopoeia , 5.1.6 Alternative Methods for Control of Microbiological Quality. in PharmEuropa, Suppl. 5.5, 4131-4142.
    • European Pharmacopoeia , 5.1.6 Alternative Methods for Control of Microbiological Quality. in PharmEuropa, Suppl. 5.5, 4131-4142.
  • 5
    • 55749086937 scopus 로고    scopus 로고
    • Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical CGMPs, September 2004.
    • Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical CGMPs, September 2004.
  • 6
    • 55749114700 scopus 로고    scopus 로고
    • Risk-Based CMC Review and Quality Assessment: What is Quality by Design (QbD)
    • School of Pharmacy, Temple University, March 29
    • Nasr, Moheb M., "Risk-Based CMC Review and Quality Assessment: What is Quality by Design (QbD)." 2006 FDA/Industry Conference. School of Pharmacy - Temple University, March 29, 2006.
    • (2006) 2006 FDA/Industry Conference
    • Nasr, M.M.1
  • 9
    • 33947380122 scopus 로고    scopus 로고
    • Rapid Methods and Automation in Microbiology Comprehensive Rev
    • Fung D.Y.C. Rapid Methods and Automation in Microbiology Comprehensive Rev. in Food Science and Food Safety 1:3-22, 2002.
    • (2002) Food Science and Food Safety , vol.1 , pp. 3-22
    • Fung, D.Y.C.1
  • 10
    • 55749092238 scopus 로고    scopus 로고
    • Detection of microbial contaminants for cell therapy products: Validation of an automated microbial detection system
    • ed. Miller M, Parenteral Drug Association, Bethesda, MD, pp
    • du Moulin, GC, Kielpinski G, Prinzi S, Duguid J, and Price A. "Detection of microbial contaminants for cell therapy products: Validation of an automated microbial detection system" in Encyclopedia of Rapid Microbiological Methods, ed. Miller M., Parenteral Drug Association, Bethesda, MD, pp273-290, 2005.
    • (2005) Encyclopedia of Rapid Microbiological Methods , pp. 273-290
    • du Moulin, G.C.1    Kielpinski, G.2    Prinzi, S.3    Duguid, J.4    Price, A.5
  • 12
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    • Identifying bacterial contaminants in a pharmaceutical manufacturing facility by gas chromatographic fatty acid analysis
    • Olsen WP, Groves MJ Klegerman ME (1990) Identifying bacterial contaminants in a pharmaceutical manufacturing facility by gas chromatographic fatty acid analysis. Pharm Technol 14:32-36.
    • (1990) Pharm Technol , vol.14 , pp. 32-36
    • Olsen, W.P.1    Groves, M.J.2    Klegerman, M.E.3
  • 13
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    • Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins
    • Eldering JA, Felten C, Veilleux CA, Potts BJ (2004) Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins. Biologicals 32:183-193.
    • (2004) Biologicals , vol.32 , pp. 183-193
    • Eldering, J.A.1    Felten, C.2    Veilleux, C.A.3    Potts, B.J.4
  • 14
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    • Miller MJ. Foreword in Encyclopedia of Rapid Microbiological Methods ed. Miller, M., Parenteral Drug Association, Bethesda MD ppxix-xxiv, 2005.
    • Miller MJ. Foreword in Encyclopedia of Rapid Microbiological Methods ed. Miller, M., Parenteral Drug Association, Bethesda MD ppxix-xxiv, 2005.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.