9. The FDA reviews information that goes on a drug’s professional labeling (information on how to use the drug). 10. The FDA inspects the facilities where the drug will be manufactured as part of the approval process. The quality of clinical data The FDA relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials and to verify the quality and integrity of data submitted, the FDA’s Division of Scientific Investigations (DSI) conducts inspections of clinical investigators’ study sites. DSI also reviews the records of institutional review boards to ensure they are fulfilling their role in patient protection. DSI seeks to determine such things as whether the study was conducted according to the investigational plan, whether all adverse events were recorded, and whether the subjects met the inclusion/exclusion criteria outlined in the study protocol. Following each inspection, FDA investigators prepare a report summarizing any deficiencies. In cases where they observe numerous or serious deviations, such as falsification of data, DSI classifies the inspection as “official action indicated” and sends a warning letter or a Notice of Initiation of Disqualification
11. FDA reviewers will approve the application or find it either “approvable” or “not approvable.”
Proceedings and Opportunity to Explain (NIDPOE) to the clinical investigator, specifying the deviations that were found. The NIDPOE begins an administrative process to determine whether the clinical investigator should remain eligible to receive investigational products and conduct clinical studies. CDER conducts about 300 to 400 clinical investigator inspections annually. About 3 percent are classified in this “official action indicated” category. The FDA established an independent Drug Safety Oversight Board (DSOB) in 2005 to oversee the management of drug safety issues and communication to the public about the risks and benefits of medicines (FDA, 2016). The board’s responsibilities include conducting timely and comprehensive evaluations of emerging drug safety issues, selecting drugs to be placed on a drug watch website for health professionals and patients, and ensuring that experts both inside and outside of the FDA give their perspectives to the agency.
DRUG NOMENCLATURE
on the use of a brand name, the most widely accepted and familiar name may become the official or generic name. (Smith-Marsh, 2018) Sources of drug preparations There are five main sources from which drugs are obtained: 1. Mineral : Many mineral substances found in nature are used in drugs. Examples : Iodine; zinc oxide; and magnesium sulfate (Epsom salt). 2. Plant : Certain drugs are derived from vegetables and plants. Examples : Digitalis; morphine; and senna pod extract. 3. Animal : The organs, tissues and body fluids of animals (including man) are the source of some drugs. Examples : Hormones; antitoxic serums; and gamma globulin from human blood. 4. Synthesis : Synthesis is the artificial building up of a chemical compound by the union of its elements. Drugs such as epinephrine that were once available only from natural sources can now be artificially reproduced through synthesis. Other drugs such as the sulfonamides were originally created through synthesis. 5. Microorganisms : Chemical substances produced by microorganisms such as fungi and bacteria are also sources of drugs. Examples : Penicillin; tetracycline; and vaccines. Solid preparations: ● Capsule : A drug placed in a gelatin container. ● Tablet : A drug compressed or molded into a flat disk or other shape. ● Pill : A powdered drug molded into a sphere. The word “pill” is often misused as a general term for tablets. ● Troche : A drug preparation in a flat disk that is held in the mouth until dissolved. ● Suppository : A drug that is molded into shape for insertion into a body opening other than the mouth. Its vehicle, such as cocoa butter, melts at body temperature and the drug is released. ● Ointment : A drug suspended in a semi-solid base such as petrolatum. ● Powder : A drug that is ground up and used in powder form. Fluid preparations: ● Fluid extract : A concentrated fluid preparation. Fluid extracts are 100 percent-strength (1 ml. of the preparation contains 1 gram of the crude drug).
Three name classifications of drugs are the chemical, or scientific name; the generic name; and the brand or trade name: ● Chemical (scientific) name : Drugs often have several names. When a drug is first discovered, it is given a chemical name, which describes the atomic or molecular structure of the drug. The chemical name is thus usually too complex and cumbersome for general use. Next, a shorthand version of the chemical name, or a code name (such as RU 486), is developed for easy reference among researcher. ● Generic name : The generic or official name of a drug is assigned by its producer in collaboration with the Food and Drug Administration and Council on Drugs of the American Medical Association. The United States Adopted Names (USAN) assigns the generic name, which may be used by any interested party. A generic drug name is not capitalized; for example, aluminum hydroxide. ● Brand, proprietary or trade name : Trade names are copyrighted terms selected by a manufacturer to designate a particular product. Copyright laws prevent any other person from using the name, and other laws prevent pharmacists from substituting chemically identical products for the trade name article. When there are no longer any legal restrictions Types of drug preparations Drugs are compounded into various types of preparations, depending upon each drug’s physical characteristics, its intended purpose, and the method of administration. Some drugs are prepared in more than one form so they may be administered several ways. To give them bulk or form, drugs may be mixed with other substances that have no action or medicinal value. These substances are called vehicles . For a drug in aqueous solution, water is the vehicle; for a drug in an ointment, fatty substances, such as petrolatum or lanolin, are used as the vehicle. Drugs or drug mixtures that are divided into definite doses are dosage forms. Examples of dosage forms are capsules, tablets, ampules and cartridge units. Some dosage forms prepared for oral administration are enteric coated with a special coating that resists the action of the stomach juices but dissolves in the intestine. This helps prevent nausea, irritation of the stomach lining or destruction of the drug. Scored tablets are marked with an indented line across the surface so that they can be broken in half when half a tablet is the dose required. Drugs prepared with flavored coatings or in flavored vehicles are exceptionally hazardous to children if left where they have access to them.
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Book Code: MTX1324B
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