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• Lectures

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• What is a phase I study?

  Human pharmacology 
  - assess tolerance
  - define/describe PK and PD
  - explore drug metabolism and drug interacitons
  - estimate activity
  
  The initial administration of an investigational new drug into humans. 
  Signfiicant potential toxicity is tested. 
  - estimation of initial safety and tolerability
  - pharmakokinetics
  - pharmacodynamics
  - early measurement of drug ativity

• What is a phase II activity?

  Therapeutic exploratory
  - explore use for the targeted indication
  - estimate dosage for subsequent studies
  - provide basis for confirmtory study design endpoint, methodologies
  
  You do this with a homogeneous population, which is closely monitored. 
  You determine the dose and regiment for phase III. 
  
  Furthermore evaluation of potential study endpoints, therapeutic regimens and target populations.

• What is phase IV?

  Therapeutic use.
  - less common side affects
  - refine dosing recommendation
  - refine understanding of benefits/risk relationship in general or special populations and/or environments   
  
  This begins after drug approval and is related to the approved indication.
  Studies are not necessary for approval, but important for optimising the drug's use.

• What are stud endpoints?

  Respones variables that are chosen to assess drug effects that are related to pharmacokinetic pramters, pharmacodynamic measures, efficacy and saety.

• What is the primary endpoint?

  clinically relevant effects and is typically selected based on the principal objective of the study

• What is the secondary endpoint?

  Assess other drug effects that may or may not be related to the primary endpoint

• What is a case-control study?

  Case series with a control group. 
  You select on disease. 
  You can use this when the outcome is rare. 
  You can't estimate the risk of the disease, but you can estimate the relative risk.

• What is a cohort study?

  You select on exposure.
  
  You can calculate the absolute risk and the relative risk. 
  
  Prospective: we start with a group of people with and without exposure, and we follow them until they get disease, but this is very inefficient. 
  Retrospetive: sometobyd in the past selected a group of people for which they recorded exposure and non-exposure, and we can see who got the disease. We did not select on disease, we have the entire group and waited for the disease.

• How do you sample your study population?

  In a case-control study you call it the source population. You first sample the cases, than the controls. 
  In cohor tstudy you firs take the samples and wait for the disease to occur.

• What are the main differences between follow-up and case-control study.

  Follow-up:
  - people without the illness who may or may not be exposed to the risk factor
  - absolute risk and relative risk
  - arises when the illness is determined
  - slow and inefficient
  - not suitable for rare illness
  - suitable for rare exposure
  
  Case-control
  - people with or without the illness
  - relative risk
  - arises when the risk factors are determined
  - fast and efficient
  - suitable for rare disease
  - not suitable for rare exposures