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A calibration curve plot showing limit of detection (LOD), limit of quantification (LOQ), dynamic range, and limit of linearity (LOL).. In analytical chemistry, a calibration curve, also known as a standard curve, is a general method for determining the concentration of a substance in an unknown sample by comparing the unknown to a set of standard samples of known concentration. [1]
The LoQ is the limit at which the difference between two distinct signals / values can be discerned with a reasonable certainty, i.e., when the signal is statistically different from the background. The LoQ may be drastically different between laboratories, so another detection limit is commonly used that is referred to as the Practical ...
The challenge to date with PAT for pharmaceutical manufacturers is knowing how to start. A common problem is picking a complex process and getting mired in the challenge of collecting and analyzing the data. The following criteria serve as a basic framework for successful PAT roll-outs: (From A PAT Primer) Picking a simple process.
Explore the concept of PK/PD models, which integrate pharmacokinetics and pharmacodynamics to optimize drug dosing and efficacy.
Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.
Pharmaceutical medicine is a medical discipline concerned with the discovery, evaluation, registration, monitoring and clinical aspects of pharmaceutical development. [ 1 ] [ 2 ] [ 3 ] All medical specialties overlap to some extent, and likewise the boundaries of pharmaceutical medicine are elastic.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
Pharmaceutical Research is an official journal of the American Association of Pharmaceutical Scientists and covers research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval.