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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
Each unit operation follows the same physical laws and may be used in all relevant chemical industries. For instance, the same engineering is required to design a mixer for either napalm or porridge, even if the use, market or manufacturers are very different. The unit operations form the fundamental principles of chemical engineering.
Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]
It forms the basis for design, manufacture, and distribution of drug products and serves as the foundation for the stable and proper use of medical drugs. [2] It covers areas such as solubility, pharmacokinetics and drug delivery. Physical pharmacy serves as principles that guide the pharmaceutical developments. [2]
Explore the concept of PK/PD models, which integrate pharmacokinetics and pharmacodynamics to optimize drug dosing and efficacy.
Another method for drug discovery is de novo drug design, in which a prediction is made of the sorts of chemicals that might (e.g.) fit into an active site of the target enzyme. For example, virtual screening and computer-aided drug design are often used to identify new chemical moieties that may interact with a target protein.
Drug design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. [1] The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein , which in turn results in a ...
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process.CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes.