عدد الرسائل : 112
العمر : 29
بلدك : اليمن
نقاط : 242
تاريخ التسجيل : 18/07/2010
|موضوع: Pharmaceutical Terminology 22/10/2010, 06:23|| |
• Accuracy: Indicates how closely an analytical or assay procedure approaches the true value for a particular sample. (Note that this requires knowing what the true value is.)
• Adjuvant: A material that enhances the action of a drug or antigen
• Alcohol: Unless otherwise specified, ethyl alcohol (ethanol). Concentration is normally in percent by volume. "Dehydrated alcohol", or "Absolute alcohol" is 100%.
• Analyte: The specific substance to be determined in an assay or analysis
• Assay, Analysis: Properly, an 'assay' determines how much of some particular material is in the sample (such as an assay for the Aspirin contentof Aspirin tablets).An 'analysis' generally determines (more or less) everything in the sample. An analysis of a rock would determine the content of calcium, magnesium, lithium, . . . . , and the length of the list would depend primarily on the sensitivity of the analysis.Both assays and analyses generally use similar procedures and instruments, but an analysis may be qualitative, reporting what is detected, or quantitative, reporting how much is found. An assay is always quantitative.
• Bioavailability: Indicates measurement of the rate and amount of drug that reaches the general circulation from an administered dosage form.
• Bioequivalence: Indicates that a drug in two or more similar dosage forms reaches the general circulation at the same relative rate and the same relative extent.
• Compendial: Official; purported to comply with USP or NF.
• CS: Colorimetric solution (defined in USP/NF).
• Disintegration: Breaking up of a tablet in water or in simulated gastric and/or simulated intestinal fluid to the point that the particles pass through a fine screen.
• Dissolution: Generally, dissolving; but specifically, a USP test which determines how rapidly the active ingredients of a dosage form dissolve. The test is generally done with six tablets in containers with very specifically defined dimensions, stirring mechanisms, etc.
• Dosage form: refers to the delivery system of a drug, i.e. cream, IV solution, or tablet.
• Excipient: Any component other than the active substance(s) that is intentionally added to the formulation of a dosage form; "added substance". The term includes binders, fillers, disintegrants, and lubricants.
• Expiration date: A date, determined by stability tests, after which the product may not meet the USP requirements. Expiration dates are generally limited to no more than 3 years after production, but longer stability periods are allowed for some very stable materials such as sulfur or sodium chloride.
• G: If followed by a number, a chromatographic phase; e. g., G4 is diethylene glycol succinate polyester. Defined in USP/NF.
• GCP: Good Clinical Practice : requirements for tests on human subjects
• GLP: Good Laboratory Practice: in the pharmaceutical context, requirements for 'nonclinical' tests on animals. It does not cover chemical or microbiological testing of raw materials or products.
• GMP: Good Manufacturing Practice: in the pharmaceutical context,these are the requirements covering all aspects of pharmaceutical manufacture, including chemical and microbiological testing of raw materials and products.
• Identification: In USP, a relatively quick presumptive test to verify that a material is what the label says it is. These are not final proof of identity, and related substances may have the same tests.
• L: If followed by a number, a chromatographic column packing. E. g.: L1 is octadecyl silane chemically bonded to porous silica or ceramic particles 3 to 10 µm in diameter. Defined in USP/NF.
• Label: The information on the 'immediate' container of a an item.
• Labeling: Information on the label and all other material accompanying the product.
• LAL: Limulus amoebocyte lysate: an in vitro test for bacterial endotoxins
• Limit of detection: The lowest concentration of an analyte that can be detected reliably (present or absent) in a particular sample. Exact definitions vary.
• Limit of quantitation: The lowest concentration of an analyte that can be determined quantitatively (at acceptable precision) in a particular sample. Exact definitions vary.
• Limit tests: Typically qualitative tests which show whether the concentration of a particular substance is above or below the USP/NF limit (usually for arsenic, calcium, sodium, potassium, chloride, sulfate, heavy metals, iron, or selenium). Some limit tests are much more extensive, notably those for lead and mercury. Microbial limit tests are usually for total aerobic count, or for presence of Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, or Escherichia coli in substances which are not required to be sterile.
• Linearity: A measure of how closely a graph of measurement result versus analyte concentration fits a straight line. Best stated as the range in which the measurement is linear within certain specified limits. Note that data may be 'transformed' mathematically, as in a plot of the logarithm of the measurement result versus the concentration. Note, too, that a mathematical definition will be more complex.
• Monograph: The entry in USP or NF for a specific raw material or product.
• Negligible: Not more than 0.50 mg (US)
• Official: Compendial; purported to comply with USP or NF
• Precision: Agreement of the results of several independent assays of the same sample. Usually reported as a standard deviation of a specified number of assays. Note that this is about how the measurements are related to each other, and does not indicate how near any one measurement or the mean of several measurements, is to the true value, if that is known.
• Pyrogens: Substances which cause fever if they are present in an injection. Most of them are bacterial endotoxins (lipid constituents of the cell walls of Gram-negative bacteria). The standard pyrogen test measures temperature increases in 3 rabbits. See also "LAL".
• RS: Reference standard (typically a substance carefully prepared by (or for) the US Pharmacopeial Convention)
• Range: The lowest and highest concentrations between which an assay is linear.
• Robustness: Lack of effect of deliberate variations in the analytical procedure on the result
• Ruggedness: A showing of how little measurements are influenced by being done by different analysts, in different laboratories, etc.
• S: If followed by a number, a chromatographic support. E. g., S7 is graphitized carbon with a nominal surface area of 12 m2/g. (Defined in USP/NF.)
• Stability testing: Determination of the period over which a product continues to meet the USP specifications, generally by long-term 'real time' tests at room temperature and about 65% relative humidity. Accelerated tests (40o C, 75% RH) are used to determine tentative stability periods for new formulations.
• Solubility: Stated in terms of the parts of solvent needed to dissolve one part of the solute (US):
Very soluble < 1
Freely soluble 1 - 10
Soluble 10 - 30
Sparingly soluble 30 - 100
Slightly soluble 100 - 1000
Very slightly soluble 1000 - 10,000
Insoluble > 10,000
• Solutions: w/w: percent by weight: grams per 100 g of solution
w/v: percent by volume: grams per 100 ml of solution
v/v: percent by volume in volume; ml per 100 ml of solution
• Specificity: Ability of an assay procedure to avoid interference from other materials in the sample.
• Sterility test: A test generally done on finished products which are to be injected. Direct transfer: 40 samples of the product are placed in separate containers of an aerobic growth medium (20 samples) and an anaerobic growth medium (20 samples) and incubated for at least 7 days.Membrane filtration: liquids (typically, the contents of 20containers) are forced, in a closed system, through two separate membrane filters (typically 0.45 µm pore size). Then aerobic and anaerobic growth media are placed on the separate filters and cultured for at least 7 days. No growth is allowed in any of the media.
• System suitability tests: Tests intended to determine whether a 'system' including instruments, analysts, etc., is capable of performing a particular process, test or assay
• Temperatures (USP): Freezer -10 to -20o C
Cold < 8o C
Refrigerator 2 to 8o C
Cool 8 to 15o C
Controlled room temperature 20 - 25o C
Warm 30 - 40o C
Excessive > 40o C
• TS: Test solution (defined in USP/NF for a particular test)
• Validated: Means that a method (or instrument, process, etc.) has been tested and shown to do, reliably, what it is supposed to do. For analytical methods, the testing generally covers accuracy, precision, specificity, limit of detection, limit of quantitation, linearity and range, ruggedness, and robustness.
• VS: Volumetric solution (defined in USP/NF for a particular analysis)
• ANDA: stands for Abbreviated New Drug Application, it’s a basic submission form for a drug which has already been approved, usually for products with similar active ingredients or dosages.
• Accelerated Approval: a mechanism to hasten the approval of drugs believed to have substantial benefits for patients with critical or ilnesses that are life-threatening.
• Action Letter: an official communication from the FDA to an NDA sponsor; usually containing the result of a decision.
• Adverse Event: refers to unwanted effects that come about as a result of medication.
• Advisory Committee: a panel of experts that get together to discuss safety issues of drugs.
• Analysis: establishes everything in a certain drug sample..
• Brand drug: a drug manufactured by a company.
• Clinical Trial: human studies to determine a drug’s effect from other influences.
• Compound: a synthesized or naturally prepared chemical, evaluated for its uses.
• Dose: the amount of drug dispensed at a single time.
• Drug Products: finished dosage form with a drug substance.
• Drug Substance: active ingredient used to treat and diagnose diseases.
• Effectiveness: the desired degree of a drug’s effect on a condition or disease.
• FDA: acronym for Food and Drug Administration.
• Generic drug: a cheaper, chemically similar copy of a specific drug, sold under the chemical name.
• GLP: stands for Good Laboratory Practices. It refers to the FDA guidelines that governs Non-Clinical studies from which data will be gathered.
• Identification: a fast preemptive test to validate that the authenticity of a certain material.
• Incidence Rate: the rate at which new cases of a disease or adverse reaction takes place per unit of time in a particular population.
• Informed Consent: voluntary consent by patients to be involved in a study after they have been made aware of the risks involved.
• IND: acronym for Investigational New Drug. After beginning a new round of clinical testing, a drug sponsor must submit the IND application to the FDA.
• Label: information on the direct container of a drug.
• LAL: Limulus Amoebocyte Lysate, it’s an alternate term for in vitro test for bacterial endotoxins.
• Limit of detection: the lowest concentration of an analyte to be detectable in a sample.
• Linearity: shows how closely a particular graph of measurement adheres to a straight line versus analyte concentration.
• New Drug: a drug not generally established as safe and effective after 1938.
• NDA: stands for New Drug Application. It refers to the application for FDA approval before a new drug is sold.
• NME: stands for New Molecular Entity, any previously unpatented compound which can be patented.
• Parallel Track Mechanism: a policy to make investigational AIDS and HIV-related drugs which show promise more widely available as safety and effectiveness trials are being conducted.
• Pharmacology: the science that studies the effects of drugs on living organisms.
• Phase 1: the first human clinical trials to analyze certain compounds for safety and tolerance.
• Phase 2: pilot studies to establish a drug’s effectiveness and safety in certain populations of patients with a particular disease.
• Phase 3: further trials to collect evidence on the efficacy and safety of drugs.
• Phase 4: studies performed after an approved drug is sold.
• PhRma: stands for Pharmaceutical Manufacturers Association.
• Precision: conformity of results between separate tests of the same sample.
• Postmarketing Surveillance: the continual FDA safety monitoring of drugs after they have been in the market.
• Preclinical studies: studies performed on animals or non-human subjects.
• Preferred brands: brand-name drugs on a particular plan’s ideal drug list.
• Priority Drugs: any drug that offers an advanced solution over available therapy.
• Raw Data: records of charts, hospital notes, patients, x-rays, and others; used by researchers.
• Recovery: A process to treat materials so as to prepare them for further use.
• Risk: the probability of an event happening within a specific period of time.
• Robustness: lack of real deliberate discrepancies in the analytical system on the result of a test.
• RS: stands for Reference Standard, it is used by the US Pharmacopeial Convention to refer to a carefully prepared substance.
• S: when followed by a number, a chromatographic support.
• Safety: before a drug is sold, there’s a requirement to submit test results to show it is safe under its conditions of use.
• Safety Update Report: an NDA sponsor must submit safety information affecting the use for which a drug will be approved.
• Side Effect: any other effect that takes place after a drug is consumed.
• SIP: stands for Steam in Place, it’s the process of sanitizing a piece of equipment by steam, without relocating it.
• Stability: a drug’s resistance to change in relation to its chemical and physical properties.
• Sterility test: test on finished products to be injected, to verify the presence of bacteria.
• Supplement: application for changes in a product which is already in the market.
• Surrogate Endpoint: lab result or a physical sign which may not be reveal how a patient feels or functions.
• Treatment IND: mechanism permitting investigational drugs to be used to access protocols.
• User Fees: charges for certain drug products and establishments.
•·.·´¯`·.·• (عضو سوبر) •·.·´¯`·.·•
عدد الرسائل : 1013
العمر : 29
بلدك : اليمن
احترام قوانين الملتقى :
نقاط : 1962
تاريخ التسجيل : 04/12/2007
|موضوع: رد: Pharmaceutical Terminology 22/10/2010, 09:41|| |
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