Buradasınız

Anasayfa » Content

APPLICATION OF QUALITY BY DESIGN (QBD) APPROACH TO PHARMACEUTICAL INDUSTRY

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2013

Key Words:

Author Name
Abstract (2. Language): 
Quality by Design has brought with it a newer vision towards development of pharmaceutical industry. In the development process of any pharmaceutical product quality is the most important factor. The main objective of this article is to focus on process parameters which are required to achieve a high accuracy and efficiency with a scientific understanding of design of process. A prospective and dynamic output of quality characters of achieved by a systematic approach of quality by design.
Bookmark/Search this post with
FULL TEXT (PDF): 
PDF icon ijprbs_235.pdf
  • 1
11-28
  • English

REFERENCES

References: 

1. Anurag SR and Helen W: Quality by
design for biopharmaceuticals. Nature
Biotechnology 2009; 27: 26-34.
2. Bhagyesh T: Quality by Design (QbD) in
pharmaceuticals. International Journal of
Pharmacy and Pharmaceutical Science
2012; 1: 17-29.
3. Premchandani TA and Barik BB: Quality
by Design (QBD): A tool for quality
improvement. Journal of Advances in
Pharmacy and Health Research 2011; 1: 7-
10.
4. Sandipan R: Quality by design: A holistic
concept of building quality in
pharmaceuticals. International Journal of
Pharmaceutical and Biomedical Research
2012; 3: 100-108
5. Alex E, Pascal V, Thomas S, Herve B, Ralf
G, Claire LES and James S: Application of
Review Article ISSN: 2277-8713
Ravi Tiwari, IJPRBS, 2013; Volume 2(1): 11-28 IJPRBS
Available Online At www.ijprbs.com
quality by design approach to the drug
substances manufacturing process of an Fc
fusion protein: Towards a global multistep
design space. Journal of Pharmaceutical
Science 2012; 101: 3604-3618.
6. Bryan SR and Xuhong Li: Quality by
Design and Process Analytical Technology
for Sterile Products. AAPS PharmSciTech
2011; 12: 114-118.
7. Wu H, White M and Khan MA: Quality by
Design: An integrated process analytical
technology for a dynamic pharmaceutical
co-precipitation process characterization
and process design space development.
International Journal of Pharmacy 2011;
405: 63-78.
8. Robert AL, Sau LL, Laiming L, Andre R and
Lawrence XYu: Quality by design: Concept
for ANDAs. AAPS Journal 2008; 10: 268-276.
9. Adam S, Suzzi D, Radeke C and Khinast
JG: An integrated Quality by Design (QbD)
approach design space definition of a
blending unit operation by Discrete Element
Method (DEM) simulation. European
Journal of Pharmaceutical Science 2011; 42:
106-115.

Thank you for copying data from http://www.arastirmax.com