Pharmaceutical Terminology

  • 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.
  • Accuracy: shows how closely a procedure comes up to the actual value of a sample.
  • 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.
  • Adjuvant: material that adds to the action of a drug.
  • Advisory Committee: a panel of experts that get together to discuss safety issues of drugs.
  • Analysis: establishes everything in a certain drug sample.
  • Analyte: specific substance to be examined in an analysis.
  • Bioavailability: refers to the rate and extent by which the body absorbs a drug.
  • Bioequivalence: the scientific bases whereby all generic and name brand drugs are measured up against each other.
  • Brand drug: a drug manufactured by a company.
  • Clinical Trial: human studies to determine a drug’s effect from other influences.
  • Compendial: similar to official or compliant.
  • Compound: a synthesized or naturally prepared chemical, evaluated for its uses.
  • Disintegration: to break a tablet in water until the particles are small enough to pass through a screen.
  • Dissolution: dissolving; in the context of an USP test, it refers to the rate by which active ingredients dissolve in a certain dosage.
  • Dosage Form: refers to the delivery system of a drug, i.e. cream, IV solution, or tablet.
  • 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.
  • Excipient: the addition of a compound to a dosage form, other than the active substance.
  • Expiration Date: the date whereby a product no longer meets USP requirements as stipulated by stability tests, rendering it unsafe for consumption.
  • 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.
  • Limit tests: used for salmonella or e-coli, it refers to the qualitative tests to determine if the concentration of a particular substance is within the USP limits.
  • Linearity: shows how closely a particular graph of measurement adheres to a straight line versus analyte concentration.
  • Monograph: entry in USP for a specific raw material or product.
  • Negligible: an amount not exceeding 0.50mg
  • 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.
  • Pyrogens: substances that cause fever when injected.
  • 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.
  • Solubility: refers to the parts of solvent required to dissolve a part of the solute.
  • 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.
  • System suitability tests: to establish if a system is can accurately perform certain tests.
  • 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.
  • TS: stands for Test Solution.
  • Treatment IND: mechanism permitting investigational drugs to be used to access protocols.
  • Validated: it means that the test is reliable.
  • VS: stands for Volumeric Solution.
  • User Fees: charges for certain drug products and establishments.

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