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ICH E8
| Question | Answer |
|---|---|
| What is ICH E8 | Guidance on General Considerations for Clinical Trials |
| ICH E6 covers what? | The principles and practices of trial subjects |
| Who has the responsibility to protect clinical trial subjects? | Investigator, Sponsor, FDA, and IRB |
| Any study should have a clear what? | Primary Objectives |
| What is nonclinical studies | Usually animal data that assists in the development of a protocol, helps determine dose, route, and other testing procedures |
| How many clinical drug trials phases are used. | 4 Phases: Phase 1, Phase 2, Phase 3, Phase 4 |
| Phase I Study | Most typical study, investigates human pharmacology. It is the initial administration or an investigational new drug into humans. Most commonly done in health subjects or pts. with mild conditions. |
| Phase I Study's might clinical look for the following data or safety. | Estimation of initial safety and tolerability, Pharmacokinetics, Assessment of Pharmacodynamics, Early measurement of drug activity |
| Estimation of initial safety and tolerability | Phase I: Determines tolerability of the drug and dose ranges expected to be needed in later clinical trials and to determine the nature of adverse reactions. This can be both single and multiple dose administrations |
| Pharmacokinetcs | Common in Phase I. PK is drug absoprtion, distribution, metabolism, and exceretion. |
| Pharmacodynamics | Common in Phase I. PD can provide early estimates of activity and potential efficacy and may guide the dosage and dose regimen for later trials. |
| Phase II Study | Therapeutic Exploratory, main goal is to explore therapeutic efficacy in patients. It is important during this phase to determine the dose(s) and regimens that will be used for later trials. |
| Phase III Study | Therapeutic Confirmatory. This phase determines therapeutic benefit. Usually done in a larger, specific population. |
| Phase IV Study | Therapuetic Use. Begins after drug approval. |
| Pregnant Women and studies. | In general should be excluded from clinical trials, if the trial focus is not on pregnancy. If a female becomes pregnant during trial, discontinue study; extensive follow-up is necessary. |
| Nursing Women and studies. | If a nursing women is enrolled in the trial, their babies should be monitored for the effect of the study drug. |
| What is the objectives of the trial | Need to be clearly stated and include exploratory or confirmatory characterization of safety and/or efficacy and/or PK or PD effects. What are you looking for. |
| How is the number of subjects to be determined | Influenced by the size of the disease, the objective of the study and study endpoints |
| What is study endpoints | They are the response variables that are chosen to assess drug effects that are related to PK, PD, efficacy and safety |
| What is a Primary Endpoint | Reflects clinically relevant effects and its typically selected based on the principal objective of the study. |
| What is a Secondary Endpoint | Assess other other drug effects that may or may not be related to the primary endpoint |
| What is a Surrogate Endpoint | Is an endpoint that is intended to relate to a clinically important outcome but does not in iteself measure a clinical benefit |
Created by:
kkolsch