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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).
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
High-performance thin-layer chromatography (HPTLC) serves as an extension of thin-layer chromatography (TLC), offering robustness, simplicity, speed, and efficiency in the quantitative analysis of compounds. [1] This TLC-based analytical technique enhances compound resolution for quantitative analysis.
In pharmaceutical research and development stereochemical analytical methodology may be required to comprehend enantioselective drug action and disposition, chiral purity assessment, study stereochemical stability during formulation and production, assess dosage forms, enantiospecific bioavailability and bioequivalence investigations of chiral ...
The pharmaceutical industry is an industry involved in medicine that discovers, develops, produces, and markets pharmaceutical goods for use as drugs which are then administered to (or self-administered by) patients. These medications are created and put to market for the curing or preventing of disease, as well as alleviating symptoms of ...
The extraction cell is filled with the solid sample to be examined and placed in a temperature-controllable oven. After adding the solvent, the cell is heated at constant pressure (adjustable between 0.3 and 20 MPa) up to a maximum temperature of 200°C and kept at constant conditions for a while so that equilibrium can be established.
Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure ...
A summation of relevant data and analysis from the protocol; An explanation of unexpected data and any other results not mandated by the protocol and its effects on production quality; Identify correlating effects and suggest changes to existing processes; Conclude if the process performance is adequately qualified to meet performance standards.