Cantitate/Preț
Produs
Total produse
Vezi coșul
Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products de Sarfaraz K. Niazi

Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products

Autor Sarfaraz K. Niazi
en Limba Engleză Paperback – 26 feb 2018
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.
Highlights from Liquid Products, Volume Three include:
  • practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing
  • access to what an FDA auditor would be looking for during a liquid manufacturing audit
  • issues that may arise during a US FDA inspection
  • the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines
Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (5) 28122 lei  6-8 săpt.
  CRC Press – 23 sep 2019 28122 lei  6-8 săpt.
  CRC Press – 14 oct 2024 31718 lei  6-8 săpt.
  CRC Press – 14 oct 2024 32805 lei  6-8 săpt.
  CRC Press – 23 sep 2019 37514 lei  6-8 săpt.
  CRC Press – 26 feb 2018 56410 lei  6-8 săpt.

Preț: 56410 lei

Preț vechi: 66365 lei
-15% Nou

Puncte Express: 846
Preț estimativ în valută:
10804€ • 11131$ • 9050£

Carte tipărită la comandă

Livrare economică 24 februarie-10 martie

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9781138113794
ISBN-10: 1138113794
Pagini: 400
Ilustrații: 3
Dimensiuni: 210 x 280 x 21 mm
Greutate: 0.45 kg
Ediția:Nouă
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Professional

Cuprins

REGULATORY AND MANUFACTURING GUIDANCE: Manufacturing Practice Considerations in Liquid Formulations. Oral Solutions and Suspensions. The FDA Drug Product Surveillance Program. Changes to Approved NDAs and ANDAs. Formulation Considerations of Liquid Products. Container Closure Systems. Material for Containers. Stability Testing of New Drug Substances and Products. Stability Testing: Photostability Testing of New Drug Substances and Products. Stability Testing for New Dosage Forms. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Evaluation of Stability Data. Stability Data Package for Registration Applications in Climatic Zones III and IV. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. EDQM Certification. Impurities: Guideline for Residual Solvents. Electronic Records and Signatures (CFR 21 Part 11 Compliance). GMP Audit Template, EU Guidelines. Bioequivalence Testing Protocols. Dissolution Testing of Liquid Dosage Forms. Approved Excipients in Liquid Forms. MANUFACTURING FORMULATIONS: Manufacturing Formulations..

Descriere

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.