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| Karl Wilhelm Scheele (1742-1786) |
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Definition
| Discovered lactic acid, citric acid, tartaric acid and arsenic acid. Identified glycerin, invented new methods of preparing calomel and benzoic acid and discovered oxygen |
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| Friedrich Serturner (1783-1841) |
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Definition
| German pharmacist who isolated morphine from opium which prompted a series of isolations of other active materials for medicinal plants |
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| Joseph Caventou and Joseph Pelletier |
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Definition
| Combined their talents and isolated quinine and cinchonine from cinchona and strychnine and brucine from nux vomica |
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Created in 1820 to ensure quality and uniform standards. Pharmacopeia was written with high degree of clarity and specificity
- Adopt standards for drugs, pharmaceutical ingredients and dosage forms
- Reflect the best current practices of medicine
- Provides information on tests and assay procedures for demonstrating compliance with these standards
- For individual components not combinations |
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Term
| Food and Drug Act of 1906 |
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Definition
| Required that "drugs marketed interstate comply with claimed standards for strength, purity and quality" No more false claims and declared products misbranded |
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| Food, Drug and Cosmetic Act of 1938 |
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Definition
| Sulfanilamide was used as an elixir containing diethylene glycol which killed 100 people before it was removed from the market. As a result, all new drugs had to be tested for safety and submitted to the NDA for marketing approval. They also need to be adequately labeled with directions and the FDA is now authorized to conduct surprise inspections |
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| Kefauver-Harris Amendment of 1962 |
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Definition
| Created as a result of thalidomide and requires manufacturers to prove that drugs are safe and effective before FDA market approval. All drugs must be accurately labeled, whether OTC or Rx. Prescription drugs must be clearly labeled Rx and "Caution: federal law prohibits dispensing without prescription" |
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| Durham-Humphrey Amendment of 1952 |
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Definition
| No refills without a valid prescription. Clarified dispensing obligations of pharmacists. Defined drugs that cannot be used safely without proper medical supervision. |
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| Comprehensive Drug Abuse Prevention and Control Act of 1970 |
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Definition
Established 5 schedules for classification and control of drug substances particularly those that were more likely to be abused.
Schedule I and II: High potential for abuse
Schedule III: Moderate potential for abuse
Schedule IV & V: Low potential for abuse |
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Definition
| Recent graduate who got hired to work for the FDA. She received the thalidomide case and refused to approve it for market use even though it was already being widely used throughout Europe. She was recognized and given a medal from President Kennedy when it was proven that thalidomide causes birth defects. As a result, the laws were strengthened by the FDA. |
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| Vinblastine and vincristine are extracted from this plant and used as drugs for leukemia and Hodgkin's lymphoma |
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| Less than 10 mg/ml is considered poorly soluble |
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| Preference for lipid verses preference for aqueous phase |
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| speed at which a drug substance dissolves in a medium |
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| Crystal versus amorphous versus powder, etc. Will alter the rate and extent of absorption |
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| Retention of drug substances within dosage form |
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| Closet agent to the goal drug possessing the fundamental desired biologic or pharmacologic activity. It may not contain all of the properties of the desired compound, and so medicinal chemists often modify the lead compound |
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| Cancer of Drug Evaluation assesses the benefits and risks of the drug. Also decides if the drug gets approved, what are the other issues of the drug, is it a high priority drug? |
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| Investigational New Drug Application |
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Definition
| Protects the rights and safety of subjects and makes certain that the research objectives stated can be achieved with the investigational plan. The IND is then assigned to a CDER official |
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Definition
| 20 - 100 patients; less than 1 year; purpose is to determine toxicology, metabolism and pharmacologic actions. Application contains: the plan for the study, chemical structure, animal testing results and manufacturing information |
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| 100 - 300 patients; determines compound's effectiveness; the patients have the disease that the drug is intended to heal; extensive pharmacologic, toxicological and pharmacological testing |
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Definition
| 1000-3000 patients; to determine long term safety and efficacy of drug product; carried out several years. How well does the drug treat the disease or condition? What are the short term side effects and risks associated with drug use in patients whose health is impaired? Investigational drug will be used in several randomized, controlled studies in various research facilities. |
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Term
| Minimum effective concentration |
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Definition
| MEC; The minimum dose required to get a desired effect |
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Term
| Minimum toxic concentration |
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Definition
| MTC; Administering drugs above this level will produce dose related toxicities |
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| MED; This dose will produce a desired intensity of a drug effect in 50% of the individuals tested |
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| Neonatal, pediatric and geriatric patients |
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| Milligrams (of drug)/per kilogram of body weight |
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| Men and woman have different responses to certain drugs due to biochemical and physiologic factors |
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| Ability to endure influence of a drug |
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| A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture |
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| The use of validated in process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned |
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| Documented testimony by qualified authorities that a system qualification, calibration, validation or revalidation has been performed appropriately and that the results are acceptable |
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| Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards and practices |
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| Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product |
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| A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo |
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| Any component other than the active ingredients in a drug product |
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| A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number |
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| Lot number, control number or batch number |
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| Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding and distribution of a batch or lot of a drug product may be determined |
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| Record containing the formulation, specifications, manufacturing, procedures, quality assurance requirements, and labeling of a finished product |
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| Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately |
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| A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality |
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| The regulatory process through which industry measures actual quality performance, compares it with standards and acts on the difference |
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| An organizational element designated by a firm to be responsible for the duties relating to quality control |
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| An area that is marked, designated or set aside for the holding of incoming components prior to acceptance testing and qualification for use |
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| A sample that accurately portrays the whole |
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| The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process |
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| The concentration of the drug substance per unit dose or volume |
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| Signed by a second individual or recorded by automated equipment |
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| Documented evidence that a system does what it purports to do |
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| Documented evidence that a process does what it purports to do |
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| A prospective experimental plan to produce documented evidence that the system has been validated |
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| Written documentation is required to make sure that each drug product has |
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Definition
| Correct identity, strength, quality and purity |
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| FDA modernization act of 1997 |
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Definition
| Ensured patients access to compounded products; prevented unnecessary FDA regulation of health professional (pharmacy) practice, but did not exempt the drug manufacturing company |
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Term
| Which container is better and why? Plastic or glass |
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Definition
| Glass because it won't change in container material over time, there is no absorption of drug to container, no leaching of constituents of container and no change in permeability |
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| What needs to be included on a prescription label? |
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Definition
| Name and address of pharmacy, serial number of prescription, date of prescription, name of the prescriber, name of patient, directions for use |
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| What needs to be included on an OTC label? |
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Definition
| Product name, net quantity of contents, pharmacologic category, cautions and warnings, sodium content, storage conditions |
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| Storage conditions (temperatures) defined by the USP |
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Definition
Cold: 8 C
Cool: 8 - 15 C
Room temp: 20 - 25 C
Warm: 30 - 40 C
Excessive heat: above 40 C |
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Definition
| A characteristic of a pure substance is a defined melting point. If not pure, the substance will exhibit a change in melting point. Commonly used to determine the purity of a drug substance and in some cases, the compatibility of various substances before inclusion in the same dosage form |
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Definition
| Represents the melting point as a function of composition of 2 or 3 component systems. Starting from the extremes of either pure A or pure B, as the second component is added, the melting point of the pure component decreases. Equal amounts of both could result in a eutectic point where a minimum melting point occurs. Never stay at this position for too long before it becomes disastrous |
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Definition
| Measure of a substances acidity; can be adjusted to enhance solubility |
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| Other techniques used to adjust pH |
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Definition
| Co-solvents, micronization, dispersion, emulsion |
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Definition
Time it takes for a drug to dissolve in fluids at the absorption site. The rate limiting step in the absorption process.
Absorption rate will increase with decrease in particular size
Dissolution will increase with increase in solubility
Dissolution can influence duration of therapeutic effect |
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Transfer of drugs from an area of high concentration (c1) to an area of low concentration (c2).
dQ/dt=DA/h(c1-c2)
dQ/dt : rate of drug diffusion
D : diffusion coefficient for drug
A : surface are across which transfer occurs
h : thickness of the region through which diffusion occurs |
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Optimal balance between water and lipid solubility
P = conc. of drug in octanol / conc. of drug in water |
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| A drug substance composed of finely divided particles or a type of pharmaceutical preparation, a medicated powder intended for internal or external use |
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| The process of rubbing, crushing, grinding or pounding materials |
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| The process of reducing the particle size and grittiness |
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| A small amount of some liquid added to the powder to form a paste |
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Definition
A spatula moves through powders on a sheet of paper or ointment tile
-Not recommended for large quantities
-Ideally suited for mixing solid substances that form eutectic mixtures when in close and prolonged contact with one another
-Mixing agents are phenol, camphor and menthol |
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| May be employed to comminute and mix powders. Glass mortar is preferred if no need for comminution. During geometric dilution an inert color is added to ensure uniform distribution |
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| Powders are mixed by passing them through sifters. Not acceptable for incorporation of potent drugs into a diluent powder |
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| Another method of mixing; powder enclosed in a rotating container. Special blenders mix/blend powders by tumbling motion. Most widely used in the pharmaceutical industry |
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| Internal and external use; external use are dusted on affected area from a sifter-type container or applied from a powder aerosol. Oral use intended for local effects (laxatives) or systemic effects (analgesics). Oral powders have faster rates of dissolution for systemic use than solid forms. |
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| Prepared agglomerates of smaller particles of powder. Usually 4 - 12 sieve size range. Prepared when blended powders are moistened and passed through a screen or special granulator. Dried until pasty mass is formed. |
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| Dissolution rate or particles |
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| Micronization of particles can increase the rate of drug dissolution and its bioavailability |
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| Particles intended to remain undissolved but uniformly dispersed in a liquid vehicle |
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| Particles intended to be inhaled for deposition deep in the respiratory tract (1 - 5 microns) |
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| Solid particles in dermal ointments, creams and ophthalmic preparations (50 - 100 microns) |
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| Particles pass through a series of sieves of known successively smaller sizes: 40 - 9500 micron |
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| Calibrated grid background is used to measure particle size: 0.2 - 100 micron |
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| Velocity of particles through a liquid medium in a gravitational or centrifugal environment: 0.8 - 300 micron |
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| Reduction in the amount of light reaching the sensor as the particle dispersed in liquid or gas passes through the sensing zone range: 0.02 - 2000 micron |
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| Pulsed laser is fired through an aerosolized particle spray and photographed in three dimensions with a camera: 1.4 - 100 micron |
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| Driven by airstream impacts on a surface in its path, particles are then separated into various size ranges by successively increasing velocity of the airstream: no specific size range |
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| Granules (coarse to very coarse powders) containing medicinal agent in a dry mixture composed of sodium bicarbonate, citric acid and tartaric acid |
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