Understanding Pharmaceutical Quality by Design
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 4
Abstract
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.
Authors and Affiliations
Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, Janet Woodcock
Keywords
Related Articles
- EP ID EP681715
- DOI 10.1208/s12248-014-9598-3
- Views 103
- Downloads 0
Antinociceptive Effects of Racemic AM1241 and Its Chirally Synthesized Enantiomers: Lack of Dependence upon Opioid Receptor Activation
The online version of this article (doi:10.1208/s12248-009-9170-8) contains supplementary material, which is available to authorized users.
Microdialysis of large molecules
Microdialysis has been used in many tissues, including skin, brain, adipose tissue, muscle, kidney, and gastrointestinal tract, to recover low-molecular mass endogenous mediators, metabolites, and xenobiotics from the in...
Recent Advances in Application of Pharmacogenomics for Biotherapeutics
Biotherapeutics (BTs), one of the fastest growing classes of drug molecules, offer several advantages over the traditional small molecule pharmaceuticals because of their relatively high specificity, low off-target effec...
Bioequivalence Requirements in the European Union: Critical Discussion
The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and present US Food a...
Engineered Mannitol Ternary Additives Improve Dispersion of Lactose–Salbutamol Sulphate Dry Powder Inhalations
The online version of this article (doi:10.1208/s12248-013-9476-4) contains supplementary material, which is available to authorized users.