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£52.00

LAP Lambert Academic Publishing Process Validation of an Anticancer Drug

Name: Process Validation of an Anticancer Drug
Brand: LAP Lambert Academic Publishing
Price: 52.0 GBP
Availability: InStock

Pharmacology

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Description

The process validation of dosage form is one of the most important regulatory requirements for pharmaceutical industry. It shows the documented evidence about the quality of the product by validating the whole manufacturing process. According to USFDA, process validation is the collection and evaluation of data, from the design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality attributes. The aim of current study was to prospectively validate the manufacturing process of tablets of drug X and assure that product meets predetermined specifications and quality attributes as per FDA and cGMP requirements. To achieve the said goal, a robust validation protocol was designed wherein critical process parameters were identified. Certain routine in-process evaluation tests and challenge studies were performed. Also tests on finished product were executed.

Product Specifications

Brand: LAP Lambert Academic Publishing
Format: paperback
ASIN: 6204979469
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Other Branches of Medicine > Pharmacology
Domain: Amazon UK
Release Date: 29 June 2022
Listed Since: 24 July 2022

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LAP Lambert Academic Publishing Process Validation of an Anticancer Drug

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