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Dissolution Testing
In the pharmaceutical industry, drug ''dissolution testing'' is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.Bai, G., Wang, Y., Armenante, P. M., "Velocity profiles and shear strain rate variability in the USP Dissolution Testing Apparatus 2 at Different Impeller Agitation Speeds, " International Journal of Pharmaceutics, 403 (1-2), Pages 1–14, 2011 There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets. (ii) Equivalence decisions: during generic product development, and also when ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
In Vitro
''In vitro'' (meaning ''in glass'', or ''in the glass'') Research, studies are performed with Cell (biology), cells or biological molecules outside their normal biological context. Colloquially called "test-tube experiments", these studies in biology and its subdisciplines are traditionally done in labware such as test tubes, flasks, Petri dishes, and microtiter plates. Studies conducted using components of an organism that have been isolated from their usual biological surroundings permit a more detailed or more convenient analysis than can be done with whole organisms; however, results obtained from ''in vitro'' experiments may not fully or accurately predict the effects on a whole organism. In contrast to ''in vitro'' experiments, ''in vivo'' studies are those conducted in living organisms, including humans, known as clinical trials, and whole plants. Definition ''In vitro'' (Latin language, Latin for "in glass"; often not italicized in English usage) studies are conducted ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dissolution Units
Dissolution may refer to: Arts and entertainment * ''Dissolution'', a 2002 novel by Richard Lee Byers in the War of the Spider Queen series * ''Dissolution'' (Sansom novel), by C. J. Sansom, 2003 * ''Dissolution'' (Binge novel), by Nicholas Binge, 2025 * ''Dissolution'' (Olivia Block album), 2016 * ''Dissolution'' (The Pineapple Thief album), 2018 * "Dissolution", a 2001 TV episode of ''Spaced'' Politics and law * Dissolution (politics), when a state or institution ceases to exist ** Dissolution of parliament *** Dissolution of the Parliament of the United Kingdom * Dissolution (law), any of several events that terminate a legal entity such as a marriage, adoption, corporation, or union * Dissolution of the Monasteries, in England, Wales and Ireland 1536–1541 Other uses * Dissolution (chemistry) Solvations describes the interaction of a solvent with dissolved molecules. Both ionized and uncharged molecules interact strongly with a solvent, and the strength and nature ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Manufacturing
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling Milling may refer to: * Milling (minting), forming narrow ridges around the edge of a coin * Milling (grinding), breaking solid materials into smaller pieces by grinding, crushing, or cutting in a mill * Milling (machining), a process of using ro ..., Granulation (process), granulation, Coated tablet, coating, tablet pressing, and others. Scale-up considerations Cooling While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale. The cost to cool a typical reactor to this temperature is large, and the viscosity of the reagents typically also increases as the temperature lowers, leading to difficult mixing. This results in added costs to stir harder and replace part ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
HPLC
High-performance liquid chromatography (HPLC), formerly referred to as high-pressure liquid chromatography, is a technique in analytical chemistry used to separate, identify, and quantify specific components in mixtures. The mixtures can originate from food, chemicals, pharmaceuticals, biological, environmental and agriculture, etc., which have been dissolved into liquid solutions. It relies on high pressure pumps, which deliver mixtures of various solvents, called the mobile phase, which flows through the system, collecting the sample mixture on the way, delivering it into a cylinder, called the column, filled with solid particles, made of adsorbent material, called the stationary phase. Each component in the sample interacts differently with the adsorbent material, causing different migration rates for each component. These different rates lead to separation as the species flow out of the column into a specific detector such as UV detectors. The output of the detector is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rutgers University
Rutgers University ( ), officially Rutgers, The State University of New Jersey, is a Public university, public land-grant research university consisting of three campuses in New Jersey. Chartered in 1766, Rutgers was originally called Queen's College and was affiliated with the Reformed Church in America, Dutch Reformed Church. It is the eighth-oldest college in the United States, the second-oldest in New Jersey (after Princeton University), and one of nine colonial colleges that were chartered before the American Revolution.Stoeckel, Althea"Presidents, professors, and politics: the colonial colleges and the American revolution", ''Conspectus of History'' (1976) 1(3):45–56. In 1825, Queen's College was renamed Rutgers College in honor of Colonel Henry Rutgers, whose substantial gift to the school had stabilized its finances during a period of uncertainty. For most of its existence, Rutgers was a Private university, private liberal arts college. It has evolved into a Mixed-sex ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New Jersey Institute Of Technology
New Jersey Institute of Technology (NJIT) is a Public university, public research university in Newark, New Jersey, United States, with a graduate-degree-granting satellite campus in Jersey City. Founded in 1881 with the support of local industrialists and inventors, especially Edward Weston (chemist), Edward Weston, NJIT opened as Newark Technical School in 1885 with 88 students. As of fall 2022 the university enrolls 12,332 students from 92 countries, about 2,500 of whom live on its main campus in Newark's University Heights, Newark, University Heights district. NJIT offers 51 undergraduate (Bachelor of Science/Arts) majors and 71 Graduate school, graduate (Masters and PhD) programs. Via its Honors College, it also offers professional programs in Healthcare and Law in collaboration with nearby institutions including New Jersey Medical School, Rutgers Medical School and Seton Hall Law School. Cross-registration with Rutgers University-Newark which borders its campus is also av ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Computational Fluid Dynamics
Computational fluid dynamics (CFD) is a branch of fluid mechanics that uses numerical analysis and data structures to analyze and solve problems that involve fluid dynamics, fluid flows. Computers are used to perform the calculations required to simulate the free-stream flow of the fluid, and the interaction of the fluid (liquids and gases) with surfaces defined by Boundary value problem#Boundary value conditions, boundary conditions. With high-speed supercomputers, better solutions can be achieved, and are often required to solve the largest and most complex problems. Ongoing research yields software that improves the accuracy and speed of complex simulation scenarios such as transonic or turbulence, turbulent flows. Initial validation of such software is typically performed using experimental apparatus such as wind tunnels. In addition, previously performed Closed-form solution, analytical or Empirical research, empirical analysis of a particular problem can be used for compa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself. The ''USP'' is published in a combined volume with the ''National Formulary'' (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable ''USP'' quality standard (in the form of a ''USP-NF'' monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to ''USP'' standards include both human drugs ( prescription, over-the-counter, or otherwise) and animal drugs. ''USP-NF'' standards also have a role in US federal law; a drug or drug ingredient with a name recognized in ''USP-NF'' is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity. USP also ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Reproducible
Reproducibility, closely related to replicability and repeatability, is a major principle underpinning the scientific method. For the findings of a study to be reproducible means that results obtained by an experiment or an observational study or in a statistical analysis of a data set should be achieved again with a high degree of reliability when the study is replicated. There are different kinds of replication but typically replication studies involve different researchers using the same methodology. Only after one or several such successful replications should a result be recognized as scientific knowledge. History The first to stress the importance of reproducibility in science was the Anglo-Irish chemist Robert Boyle, in England in the 17th century. Boyle's air pump was designed to generate and study vacuum, which at the time was a very controversial concept. Indeed, distinguished philosophers such as René Descartes and Thomas Hobbes denied the very possibility of vacuum ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introductio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Accurate
Accuracy and precision are two measures of ''observational error''. ''Accuracy'' is how close a given set of measurements (observations or readings) are to their ''true value''. ''Precision'' is how close the measurements are to each other. The International Organization for Standardization (ISO) defines a related measure: ''trueness'', "the closeness of agreement between the arithmetic mean of a large number of test results and the true or accepted reference value." While ''precision'' is a description of ''random errors'' (a measure of statistical variability), ''accuracy'' has two different definitions: # More commonly, a description of ''systematic errors'' (a measure of statistical bias of a given measure of central tendency, such as the mean). In this definition of "accuracy", the concept is independent of "precision", so a particular set of data can be said to be accurate, precise, both, or neither. This concept corresponds to ISO's ''trueness''. # A combination of both ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
