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Volumn 16, Issue 8, 2003, Pages 24-34

A rational, step-wise approach to process characterization

Author keywords

[No Author keywords available]

Indexed keywords

COMMERCIAL PHENOMENA; COST EFFECTIVENESS ANALYSIS; PROCESS CONTROL; PROCESS DEVELOPMENT; REVIEW; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; VALIDATION PROCESS;

EID: 10844248476     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review
Times cited : (32)

References (14)
  • 1
    • 0032808316 scopus 로고    scopus 로고
    • The Compliance Costs of Hasty Process Development
    • August
    • Bobrowicz, G., "The Compliance Costs of Hasty Process Development," BioPharm 12(8), 35-38 (August 1999).
    • (1999) BioPharm , vol.12 , Issue.8 , pp. 35-38
    • Bobrowicz, G.1
  • 2
    • 34548291121 scopus 로고    scopus 로고
    • Identification and Establishment of Operating Ranges of Critical Process Variables
    • G. Sofer and D. Zabriskie, Eds. (Marcel Dekker Press, New York)
    • Gardner, A. and Smith, T., "Identification and Establishment of Operating Ranges of Critical Process Variables," Pharmaceutical Process Validation, G. Sofer and D. Zabriskie, Eds. (Marcel Dekker Press, New York, 1999, pp. 61-76).
    • (1999) Pharmaceutical Process Validation , pp. 61-76
    • Gardner, A.1    Smith, T.2
  • 3
    • 10844256008 scopus 로고    scopus 로고
    • Applying HACCP to Pharmaceutical Process Validation
    • October
    • Armbruster, A. and Feldsien, T , "Applying HACCP to Pharmaceutical Process Validation," BioPharm 13(10), 170-178 (October 2000).
    • (2000) BioPharm , vol.13 , Issue.10 , pp. 170-178
    • Armbruster, A.1    Feldsien, T.2
  • 4
    • 0004442159 scopus 로고    scopus 로고
    • Applications of Failure Mode and Effects Analysis in the Pharmaceutical Industry
    • September
    • Kieffer, R., et al., "Applications of Failure Mode and Effects Analysis in the Pharmaceutical Industry," Pharm Technol. Eur., 36-49 (September 1997)
    • (1997) Pharm. Technol. Eur. , pp. 36-49
    • Kieffer, R.1
  • 5
    • 0034902676 scopus 로고    scopus 로고
    • Reduction of Risk and the Evaluation of Quality Assurance
    • Nobel, P., "Reduction of Risk and the Evaluation of Quality Assurance," PDA J. Pharm. Sci. Technol 55(4), 235-239 (2001).
    • (2001) PDA J. Pharm. Sci. Technol. , vol.55 , Issue.4 , pp. 235-239
    • Nobel, P.1
  • 6
    • 0027626871 scopus 로고
    • Using Failure Mode and Effects Analysis to Improve Manufacturing Processes
    • July
    • Sahni, A., "Using Failure Mode and Effects Analysis to Improve Manufacturing Processes," Med. Dev. Diagn. Ind., 47-51 (July 1993).
    • (1993) Med. Dev. Diagn. Ind. , pp. 47-51
    • Sahni, A.1
  • 7
    • 0004242112 scopus 로고    scopus 로고
    • Productivity, Inc., Portland, OR
    • McDermott, R. et al , The Basics of FMEA (Productivity, Inc., Portland, OR, 1996).
    • (1996) The Basics of FMEA
    • McDermott, R.1
  • 9
    • 28044454148 scopus 로고    scopus 로고
    • Rath & Strong, Inc., Lexington, MA
    • Rath and Strong's Six Sigma Pocket Guide (Rath & Strong, Inc., Lexington, MA, 2001), pp. 26-31.
    • (2001) Rath and Strong's Six Sigma Pocket Guide , pp. 26-31
  • 10
    • 4043099333 scopus 로고    scopus 로고
    • Establishing Process Robustness Using Designed Experiments
    • G. Sofer and D. Zabriskie, Eds. (Marcel Dekker Press, New York)
    • Kelley, B., "Establishing Process Robustness Using Designed Experiments," Pharmaceutical Process Validation, G. Sofer and D. Zabriskie, Eds. (Marcel Dekker Press, New York, 1999), pp. 29-60
    • (1999) Pharmaceutical Process Validation , pp. 29-60
    • Kelley, B.1
  • 14
    • 0034798584 scopus 로고    scopus 로고
    • Statistical Tools for Setting in Process Acceptance Criteria
    • October
    • Seely, R , Munyakazi, L., and Haury, J., "Statistical Tools for Setting in Process Acceptance Criteria" BioPharm, 14(10), 28-34 (October 2001).
    • (2001) BioPharm , vol.14 , Issue.10 , pp. 28-34
    • Seely, R.1    Munyakazi, L.2    Haury, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.