What’s the Regulatory Value of a Target Product Profile?

2017 ◽  
Vol 35 (7) ◽  
pp. 576-579 ◽  
Author(s):  
Christopher D. Breder ◽  
Wenny Du ◽  
Adria Tyndall
Keyword(s):  
Target Product ◽  
Target Product Profile ◽  
Product Profile

Quality by Design: Concept to Applications

2019 ◽  
Vol 16 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Suryakanta Swain ◽  
Rabinarayan Parhi ◽  
Bikash Ranjan Jena ◽  
Sitty Manohar Babu
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Assessment Tools ◽  
Basic Knowledge ◽  
Target Product ◽  
Target Product Profile ◽  
Critical Material ◽  
Novel Approach ◽  
Product Profile ◽  
Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

scholarly journals The target product profile as a tool for regulatory communication: advantageous but underused

2017 ◽  
Vol 16 (3) ◽  
pp. 156-156 ◽  
Author(s):  
Adria Tyndall ◽  
Wenny Du ◽  
Christopher D. Breder
Keyword(s):  
Target Product ◽  
Target Product Profile ◽  
Product Profile

scholarly journals Using Real-World Data to Predict Clinical and Economic Benefits of a Future Drug Based on its Target Product Profile

2020 ◽  
Vol 7 (3) ◽  
pp. 221-227
Author(s):  
Christoph Gerlinger ◽  
Thomas Evers ◽  
Jeremy Rassen ◽  
Richard Wyss
Keyword(s):  
Real World ◽  
Economic Benefits ◽  
Target Product ◽  
Target Product Profile ◽  
Real World Data ◽  
World Data ◽  
Product Profile ◽  
Future Drug

scholarly journals Target Product Profile (TPP) for Chagas Disease Point-of-Care Diagnosis and Assessment of Response to Treatment

2015 ◽  
Vol 9 (6) ◽  
pp. e0003697 ◽  
Author(s):  
Analía I. Porrás ◽  
Zaida E. Yadon ◽  
Jaime Altcheh ◽  
Constança Britto ◽  
Gabriela C. Chaves ◽  
...  
Keyword(s):  
Chagas Disease ◽  
Point Of Care ◽  
Response To Treatment ◽  
Target Product ◽  
Target Product Profile ◽  
Product Profile

scholarly journals Multi-stakeholder consensus on a target product profile for an HIV cure

2021 ◽  
Vol 8 (1) ◽  
pp. e42-e50
Author(s):  
Sharon R Lewin ◽  
Timothy Attoye ◽  
Cathy Bansbach ◽  
Brian Doehle ◽  
Karine Dubé ◽  
...  
Keyword(s):  
Target Product ◽  
Hiv Cure ◽  
Target Product Profile ◽  
Product Profile ◽  
Multi Stakeholder ◽  
Stakeholder Consensus

scholarly journals Target Product Profile for a point-of-care diagnostic test for dermal leishmaniases

2019 ◽  
Vol 5 ◽  
pp. e00103 ◽  
Author(s):  
Israel Cruz ◽  
Audrey Albertini ◽  
Mady Barbeitas ◽  
Byron Arana ◽  
Albert Picado ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
Point Of Care ◽  
Target Product ◽  
Target Product Profile ◽  
Product Profile
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