Stage 1A: Quality by Design Product Development

2019 ◽  
pp. 1-36
Author(s):  
Ajay Pazhayattil ◽  
Naheed Sayeed-Desta ◽  
Emilija Fredro-Kumbaradzi ◽  
Marzena Ingram ◽  
Jordan Collins
Keyword(s):  
Product Development ◽  
Quality By Design

Pharmaceutical product development: A quality by design (QbD) approach

2021 ◽  
pp. 131-146
Author(s):  
Md Saquib Hasnain ◽  
Syed Anees Ahmed ◽  
Aisha Khatoon ◽  
Mohd Afzal ◽  
Mohammed Tahir Ansari ◽  
...  
Keyword(s):  
Product Development ◽  
Quality By Design ◽  
Pharmaceutical Product ◽  
Pharmaceutical Product Development

Quality by Design: Concept for Product Development of Dry-powder Inhalers

2015 ◽  
pp. 321-338 ◽  
Author(s):  
Al Sayyed Sallam ◽  
Sami Nazzal ◽  
Hatim S. AlKhatib ◽  
Nabil Darwazeh
Keyword(s):  
Product Development ◽  
Quality By Design ◽  
Design Concept ◽  
Dry Powder Inhalers ◽  
Dry Powder

scholarly journals Reconciling Quality by Design and Transdermal Product Development

Pharmaceutics ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 273
Author(s):  
Kenneth Miller
Keyword(s):  
Product Development ◽  
Quality By Design ◽  
Experimental Approach ◽  
Product Information ◽  
New Product ◽  
Years Of Experience ◽  
Regulatory Review

Since my first exposure to the acronym ‘QbD’ more than ten years ago, I have been trying to understand exactly what QbD is and how I might incorporate its teachings into my twenty-odd years of experience developing transdermal systems. I feel I have made little progress since then. Eventually, I came to realize that while QbD has its merits, it is not a guide for (transdermal) product development, despite so often being described as such. Instead, I have come to consider QbD as a language useful for organizing and presenting the array of data supporting the approval of a new product, but it still leaves the experimental approach entirely up to the developer. What QbD does provide to the development community is a means of conveying product information through a consistent framework facilitating both internal and regulatory review. As a result, new ‘QbD’ product applications tend to be more uniform and complete than the applications that preceded the initiative.

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design

2011 ◽  
Vol 100 (8) ◽  
pp. 3031-3043 ◽  
Author(s):  
Sheryl Martin‐Moe ◽  
Fredric J. Lim ◽  
Rita L. Wong ◽  
Alavattam Sreedhara ◽  
Jagannathan Sundaram ◽  
...  
Keyword(s):  
Product Development ◽  
Quality By Design ◽  
Drug Product

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film–Coated Tablets

2016 ◽  
Vol 105 (1) ◽  
pp. 168-181 ◽  
Author(s):  
Sherif I.F. Badawy ◽  
Ajit S. Narang ◽  
Keirnan R. LaMarche ◽  
Ganeshkumar A. Subramanian ◽  
Sailesh A. Varia ◽  
...  
Keyword(s):  
Product Development ◽  
Quality By Design ◽  
Drug Product ◽  
Design Principles ◽  
Brivanib Alaninate

scholarly journals Articulation of Quality By Design Elements for Product Development and its Unique Applications

2020 ◽  
Vol 10 (3) ◽  
pp. 253-261
Author(s):  
Dnyaneshwar Sitre ◽  
Ravindra Kamble
Keyword(s):  
Product Development ◽  
Quality By Design ◽  
Life Cycle Management ◽  
Pharmaceutical Product ◽  
Dissolution Enhancement ◽  
Management Approach ◽  
Technical Application ◽  
Design Elements ◽  
Pharmaceutical Development ◽  
Pharmaceutical Product Development

Quality by Design (QbD) is a methodical approach to pharmaceutical product development that begins with predefined objectives and emphasizes product and process comprehension and process control based on sound science and quality risk management. Pharmaceutical development should lead to the design a quality product and its manufacturing process to meet the QTPP and CQA parameters. To arrive at the robust product development QbD articulation is important which is missing in most of the reviews. This review articulates the QbD elements in the product development. QbD process stars with identification of QTPP and source CQA from QTPP. CMAs and CPPs are derived with risk assessment from the product ingredients and process. Their impact on the CQAs can be studies with DoE tools. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the design space and control strategy. Product process follows life cycle management approach with continuous improvement. PAT tools are utilized for the online monitoring of the processes. This review paper is dedicated to provide QbD element articulation in product development and its unique applications in the various areas of the product development such as Biotechnology, Nanotechnology products, Nasal products, Inhalation, Injectable products, Targeted drug delivery, complex Solid oral, Transdermal and topical products, Bioavailability and dissolution enhancement, Analytical processes and API manufacturing etc. Current trends in the technical application of the PAT tools are discussed. Keywords: Quality by Design (QbD), Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) and Design of Experiment (DoE): Product development application of QbD

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