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Volumn 12, Issue 4, 2011, Pages 1264-1275

Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products

Author keywords

biotechnological products; distribution; pharmaceutical products; stability; temperature excursions; transport

Indexed keywords

BIOTECHNOLOGICAL PRODUCTION; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; GOOD MANUFACTURING PRACTICE; METHODOLOGY; PRIORITY JOURNAL; REVIEW; TEMPERATURE SENSITIVITY; THERMOREGULATION;

EID: 83555168202     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-011-9684-0     Document Type: Review
Times cited : (61)

References (19)
  • 2
    • 83555164409 scopus 로고    scopus 로고
    • Stability testing: photostability testing of new drug substances and products-Q1B. (ICH) 6 November
    • Stability testing: photostability testing of new drug substances and products-Q1B. (ICH), International Conference on Harmonization. 6 November 1996.
    • (1996) International Conference on Harmonization
  • 3
    • 83555166956 scopus 로고    scopus 로고
    • (ICH), International Conference on Harmonization. 6 November
    • Stability testing for new dosage forms-Q1C. (ICH), International Conference on Harmonization. 6 November 1996.
    • (1996) Stability Testing for New Dosage forms-Q1C
  • 4
    • 83555161416 scopus 로고    scopus 로고
    • Bracketing and matrixing designs for stability testing of new drug substances and products-Q1D. (ICH) 7 February
    • Bracketing and matrixing designs for stability testing of new drug substances and products-Q1D. (ICH), International Conference on Harmonization. 7 February 2002.
    • (2002) International Conference on Harmonization
  • 5
    • 83555161415 scopus 로고    scopus 로고
    • Evaluation for stability data-Q1E. (ICH) 6 February
    • Evaluation for stability data-Q1E. (ICH), International Conference on Harmonization. 6 February 2003.
    • (2003) International Conference on Harmonization
  • 6
    • 83555166954 scopus 로고
    • Quality of biotechnological products: stability testing of biotechnological/biological products-Q5C. (ICH) 30 November
    • Quality of biotechnological products: stability testing of biotechnological/biological products-Q5C. (ICH), International Conference on Harmonization. 30 November 1995.
    • (1995) International Conference on Harmonization
  • 8
    • 83555174150 scopus 로고    scopus 로고
    • US Pharmacopoeia. USP. current version
    • US Pharmacopoeia. USP. current version.
  • 9
    • 83555174151 scopus 로고    scopus 로고
    • Technical Report no. 39: Cold chain guidance for medicinal products: maintaining the quality of temperature-sensitive medicinal products through the transportation environment. PDA. Originally published 2005, revised 2007
    • Technical Report no. 39: Cold chain guidance for medicinal products: maintaining the quality of temperature-sensitive medicinal products through the transportation environment. PDA. Originally published 2005, revised 2007.
  • 18
    • 83555174149 scopus 로고    scopus 로고
    • A mathematical approach to assessing temperature excursions in temperature-controlled chains
    • Claude Ammann 2008 A mathematical approach to assessing temperature excursions in temperature-controlled chains European Journal of Parenteral and Pharmaceutical Sciences 13 2 57 59
    • (2008) European Journal of Parenteral and Pharmaceutical Sciences , vol.13 , Issue.2 , pp. 57-59
    • Claude, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.