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Handbook of Pharmaceutical Manufacturing Formulations

- Volume Three, Liquid Products

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While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products presents practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing. It delineates things an FDA auditor will look for during a liquid manufacturing audit, issues that may arise during a US FDA inspection, and the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines.

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9781138113794
  • Indbinding:
  • Paperback
  • Sideantal:
  • 400
  • Udgivet:
  • 26. februar 2018
  • Udgave:
  • 2
  • Størrelse:
  • 269x214x28 mm.
  • Vægt:
  • 960 g.
  • 8-11 hverdage.
  • 7. december 2024
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Beskrivelse af Handbook of Pharmaceutical Manufacturing Formulations

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products presents practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing. It delineates things an FDA auditor will look for during a liquid manufacturing audit, issues that may arise during a US FDA inspection, and the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines.

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