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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).
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.
HPLC is widely used for manufacturing (e.g., during the production process of pharmaceutical and biological products), [4] [5] legal (e.g., detecting performance enhancement drugs in urine), [6] research (e.g., separating the components of a complex biological sample, or of similar synthetic chemicals from each other), and medical (e.g ...
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. [ 1 ] [ 2 ] It is a sub-discipline of health economics . A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of ...
With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
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In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered. [1]Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin.
Most large pharmaceutical process chemistry and manufacturing divisions have devised weighted quantitative schemes to measure the overall attractiveness of a given synthetic route over another. As cost is a major driver, material cost and volume-time output are typically weighted heavily.