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Volumn 36, Issue 1, 2008, Pages 70-75

Introducing principles of validation into biochemistry and biotechnology courses: Practical concepts and a framework for active learning

Author keywords

Methodology; Regulatory issues; Validation

Indexed keywords


EID: 38949166769     PISSN: 14708175     EISSN: None     Source Type: Journal    
DOI: 10.1002/bmb.130     Document Type: Short Survey
Times cited : (1)

References (13)
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  • 2
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    • (1998) Validation of Pharmaceutical Processes
  • 3
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    • Kirrstetter, R.1
  • 4
    • 0033168756 scopus 로고    scopus 로고
    • Quality control and assurance from the development to the production of biopharmaceuticals
    • O. Doblhoff-Dier, R. Bliem (1999) Quality control and assurance from the development to the production of biopharmaceuticals, Trends. Biotechnol. 17, 266-270.
    • (1999) Trends. Biotechnol , vol.17 , pp. 266-270
    • Doblhoff-Dier, O.1    Bliem, R.2
  • 6
    • 0034103030 scopus 로고    scopus 로고
    • Master planning and validation, Part 1: Anatomy of a validation master plan
    • A
    • J. Agalloco, G. Sofer (2000) Master planning and validation, Part 1: Anatomy of a validation master plan, Biopharm. Appl. Tech. Biopharm. Dev. 13, 10-10 A.
    • (2000) Biopharm. Appl. Tech. Biopharm. Dev , vol.13 , pp. 10-10
    • Agalloco, J.1    Sofer, G.2
  • 7
    • 3042741107 scopus 로고    scopus 로고
    • cGMP aspects in practice: Basics for the compilation of a validation master plan
    • C. Oechslein (2004) cGMP aspects in practice: Basics for the compilation of a validation master plan, Pharm. Ind. 66, 769-770.
    • (2004) Pharm. Ind , vol.66 , pp. 769-770
    • Oechslein, C.1
  • 8
    • 0002132880 scopus 로고    scopus 로고
    • Practical method validation: Validation sufficient for an analysis method
    • P. Bruce, P. Minkkinen, M. L. Riekkola (1998) Practical method validation: Validation sufficient for an analysis method, Mikromol. Chem. Acta 128, 93-106.
    • (1998) Mikromol. Chem. Acta , vol.128 , pp. 93-106
    • Bruce, P.1    Minkkinen, P.2    Riekkola, M.L.3
  • 11
    • 1342308856 scopus 로고    scopus 로고
    • Risk/science-based approach to validation: A win-win-win for patients, regulators, and industry
    • K. A. Welch, C. A. Fling, S. R. Schmidt (2004) Risk/science-based approach to validation: A win-win-win for patients, regulators, and industry, PDA J. Pharm. Sci. Technol. 58, 15-23.
    • (2004) PDA J. Pharm. Sci. Technol , vol.58 , pp. 15-23
    • Welch, K.A.1    Fling, C.A.2    Schmidt, S.R.3
  • 12
    • 17444382304 scopus 로고    scopus 로고
    • Bacterial adhesion: Considerations within a risk-based approach to cleaning validation
    • E. C. Tidswell (2005) Bacterial adhesion: Considerations within a risk-based approach to cleaning validation, PDA J. Pharm. Sci. Technol. 59, 10-32.
    • (2005) PDA J. Pharm. Sci. Technol , vol.59 , pp. 10-32
    • Tidswell, E.C.1
  • 13
    • 0141593740 scopus 로고    scopus 로고
    • GMP requirements for quality control/assurance in the manufacturing of active pharmaceutical ingredients examples from manufacturing plants
    • C. Schonborn (2003) GMP requirements for quality control/assurance in the manufacturing of active pharmaceutical ingredients examples from manufacturing plants, Pharm. Ind. 65, 695.
    • (2003) Pharm. Ind , vol.65 , pp. 695
    • Schonborn, C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.