Analytical method validation and instrument performance verification /

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of ins...

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Bibliographic Details
Call Number:Libro Electrónico
Other Authors: Chan, Chung Chow
Format: Electronic eBook
Language:Inglés
Published: Hoboken, N.J. : John Wiley & Sons, ©2004.
Subjects:
Drugs > Analysis > Methodology > Evaluation.
Laboratories > Equipment and supplies > Evaluation.
Laboratories > Instruments > Evaluation.
Chemistry, Pharmaceutical > instrumentation
Chemistry, Pharmaceutical > methods
Clinical Laboratory Techniques > standards
Technology, Pharmaceutical > methods
Médicaments > Analyse > Méthodologie > Évaluation.
Laboratoires > Instruments > Évaluation.
TECHNOLOGY & ENGINEERING > Biomedical.
MEDICAL > Family & General Practice.
MEDICAL > Allied Health Services > Medical Technology.
MEDICAL > Biotechnology.
MEDICAL > Lasers in Medicine.
Online Access:Texto completo
Table of Contents:
  • Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen
  • Potency method validation / Chung Chow Chan
  • Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee
  • Dissolution method validation / Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee.
  • Development and validation of automated methods / Chantal Incledon and Herman Lam
  • The analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang
  • Validation study of JP heavy metal limit test / Yoshiki Nishiyama
  • Bioanalytical method validation / Fabio Garofolo.
  • The procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam
  • Performance verification of UV-VIS spectrophotometers / Herman Lam
  • Performance verification of HPLC / Herman Lam.

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