- 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
- 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
- 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
- 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
- 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
- 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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