Pharmaceutical Preparations
 |
|
|---|
Pharmaceutical Preparations are defined by the National Library of Medicine as drugs intended for human or veterinary use, presented in their finished dosage form. Pharmaceutical preparations can be considered as molecular medicine applications when they reflect an approach based on understanding of details at the molecular level.
If a drug has successfully completed the clinical trial process, FDA approval can be secured. Once approval is secured, the drug can be used by health care providers and/or consumers.
Assessment
Review of the literature and personal and anecdotal knowledge of research study investigators is recommended in order to track drugs that have demonstrated efficacy in clinical studies or those that are currently in use in clinical applications for treatment of a disease, condition or disorder. Particularly helpful is a review of the literature, especially from trade publications, to locate evidence that drugs are being used by health care providers and consumers. For resources that may be helpful for review of the literature, see Knowledge Transfer: Mass Media and Knowledge Transfer: Reviews.
 |
Search using the keywords of the drug; title of the research study; the disease, disorder or condition; the specific medical specialty of the disease, disorder or condition; and name of the primary investigator/s. |
|---|
Some resources that may be helpful in locating evidence of drugs used in clinical settings include the following:
Clinical Study Results
Clinical Study Results is a central, widely accessible, web-based repository for clinical study results. The database contains results from all “hypothesis-testing” clinical studies (mainly phase III and IV studies) completed since October 1, 2002, for drug products approved in the United States. This includes both published articles and unpublished study summaries. The information provided includes the sponsoring company’s name, the proprietary and generic names of the drug, a link or reference to the FDA-approved drug label, the studied indication(s), a bibliography of published studies together with a link (where available) to the printed articles, and a summary of the results of clinical studies that have not been published. This summary presentation will include information on the drug such as the design of the trial, the number of patients studied, the dose and mode of administration, and a summary of conclusions and outcomes on the safety and efficacy of the drug.
Clinical Trials.gov
The Clinical Trials.gov database allows for searching by a number of criteria including interventions which allows for a search for a specific drug, device, procedure or vaccine. Clinical Trials.gov includes clinical trials from all sources of funding and from over 157 countries.
Cochrane Library – Clinical Trials
The Cochrane Library consists of a regularly updated collection of evidence-based medicine databases to inform healthcare decision-making. Cochrane provides additional resources such as other systematic reviews, abstracts, technology assessments, economic evaluations, and individual clinical trials.
The Cochrane Library offers a Clinical Trials database that allows for searching of clinical trials as noted in MEDLINE and EMBASE and from other published and unpublished sources. From the main page of the Cochrane Library, select the Clinical Trials resource. Search tips are noted on the main page of the Clinical Trials database.
 |
Cochrane Library home page |
Devices@FDA
Devices@FDA allows you to search for official information about FDA approved brand name and generic drugs and therapeutic biological products. Drugs@FDA allows for searching by the following criteria:
- drug name
- generic name
- active ingredient
- drug name and FDA Action Date range
- application number (NDA, ANDA, BLA)
- action dates of approvals and supplements in one, two, or three month blocks
- original and supplemental approvals by month
Additional Resources:
- Instructions for searching Drugs@FDA.
- The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective
Drug Formulary Lists
Public and private health insurance plans provide formulary listings that list drugs that are covered under healthcare benefit plans. For example, Medicare provides a database to search for formularies by state, Formulary Finder for Prescription Drug Plans and likewise for private health insurance companies, such as Highmark Blue Shield and Blue Cross Blue Shield of Michigan.
WHO Model List of Essential Medicines
The World Health Organization (WHO) updates its Model List of Essential Medicines every two years. WHO defines these essential medicines as “those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford.” The current version is the 15th edition, dated March 2007.
Back to Top
Last updated: May 4, 2009