Glossary Terms (Simple List)
-
Pharmaceutical Dosage Form
General classification of drug products based largely on their route of administration and presentation (e.g., compressed tablets, powder-filled capsules, topical creams and nasal sprays). (TR67)
-
Pharmaceutical Ingredients
Includes drug substances, excipients, processing aids and ingredient water. (TR67)
-
Pharmaceutical Quality System (PQS)
Management system to direct and control a pharmaceutical company with regard to quality. (TR54) (TR54-5)
-
Pharmacist in Charge
A licensed pharmacist who is assigned the responsibility and authority for establishing and implementing policies and procedures for all operations of the pharmacy and to ensure the pharmacy operations and practices comply with all requirements of national and local pharmacy and drug laws, rules, and regulations. (TR63)
-
Pharmacodynamics
How the drug works in the body, the biochemical and physiological effects of drug and its mechanisms of their actions. (TR56)
-
Pharmacokinetics
How the body processes the drug; the study of the movement of drugs in the body, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. (TR56)
-
Pharmacy Manual
A manual typically created and provided by the study sponsor that contains specific information and documentation to allow the clinical sites to properly receive, store, prepare, label, dispense and return clinical trial material and document the related activities at the clinical site. Note: For this report, the pharmacy manual will also contain specific instructions for the extemporaneous preparation, labeling and dispensing of clinical trial materials. (TR63)
-
Phase 1 Clinical Trials
Phase 1 trials are the first stage of testing in human subjects. Often, a small (20-100) group of healthy volunteers will be selected. For life-threatening indications such as oncology, these can be patients that have the target disease but may not yet be the ideal target population. This Phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. (TR56)
-
Phase 2 Clinical Trials
Once the initial safety of the study drug has been confirmed in Phase 1 trials, Phase 2 trials are performed on larger groups (20-300) and are designed to assess efficacy, as well as to continue safety assessments in a larger group of volunteers and patients. Phase 2a is specifically designed to assess dosing requirements (how much drug should be given). Phase 2b trials are specifically designed to study efficacy (how well the drug works at the prescribed dose(s). (TR56)
-
Phase 3 Clinical Trials
Final clinical stage Phase 3 trials are designed to demonstrate the potential advantages of the new therapy; safety and efficacy of the new therapy are studied over a longer period of time, and more patients (1,000-3,000) are enrolled in the study with less restrictive eligibility criteria. Phase 3 studies are intended to help scientists identify rarer side effects of treatment and prepare for a broader application of the product. Phase 3 trials enroll patients to verify efficacy and monitor adverse reactions during long term use. (TR56)