Handbook of Pharmaceutical Manufacturing Formulations – Vol.6: Sterile Products

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Descrição

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.
Highlights from Sterile Products, Volume Six include:
• formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
• specifications of a manufacturing facility to manufacture compliant sterile products
• NDA or aNDA filing requirements of sterile products
• an alphabetical presentation of formulations of pharmaceutical products based on their generic names

Informação adicional

Peso 3 kg
Autor

NIASI

ISBN

9781420081305

ISBN10

1420081306

Editora

Informa Healthcare

Número de Páginas

460 pags.

Idioma

Ingles

Ano

2009