소장자료

Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices [electronic resource] :

  • Huynh-Ba, Kim. editor.
  • 2009
Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices [electronic resource] :
  • 자료유형
    단행본
  • 서명/저자사항
    Handbook of Stability Testing in Pharmaceutical Development[electronic resource] :Regulations, Methodologies, and Best Practices / edited by Kim Huynh-Ba.
  • 개인저자
    Huynh-Ba, Kim., editor.
  • 단체저자
    SpringerLink (Online service)
  • 형태사항
    XVII, 389 p. 72 illus. : online resource.
  • 내용주기
    Stability Regulations -- Critical Regulatory Requirements for a Stability Program -- Understanding ICH Guidelines Applicable to Stability Testing -- Global Stability Practices -- Post-approval Changes ??Stability Requirements and Regulations -- Understanding and Predicting Pharmaceutical Product Shelf-Life -- Stability Methodologies and Best Practices -- Development of Stability Indicating Methods -- Method Validation and Transfer -- Overview of USP-NF Requirements for Stability Purposes -- Non-chromatographic Methods to Support Stability Program -- Vibrational Spectroscopic Methods for Quantitative Analysis -- Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product -- Evaluation of Stability Data -- Qualification, Calibration, and Maintenance of Stability Chambers -- Stability Operation Practices -- Other Stability Programs -- Combination Products/Drugs in Devices -- Stability Studies for Biologics.
  • 일반주제명
    Medicine.
    Pharmacology.
    Biomedicine.
    Pharmacology/Toxicology.
  • 기본자료 저록
    Springer eBooks
  • 기타형태 저록
    Printed edition: 9780387856261
  • ISBN
    9780387856278
  • 언어
    영어