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• 1 Introduction

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• What is the purpose of this course?

  To review the role of bioanalysis in the development and marketing of new drugs. Both technological aspects and regulatory aspects are covered.

• What is chemical analysis?

  It is the process of identifying the (proportions) of components in a complex material. (e.g. in environmental analysis, food analysis, material analysis or in bioanalysis)

• What is clinical chemistry?

  This is the science of analysing body fluids to diagnose a disease (laboratorium medicine)
  - it is typically performed by hospital laboratories,
  - it is highly standardized and there is a high level of automation
  
  e.g. creatinine, bilirubin, cholesterol, glucose, potassium, sodium etc.

• What is therapeutic drug monitoring?

  It is the science of determining medication levels in blood to help establishing proper dosing (drugs with a narrow therapeutic range (e.g. gentamicin, valproic acid, cyclosporin, phenytoin etc.)
  This is typically performed by hospital laboratories as well.
  - It is also highly standardized and has a high level of automation as well.

• What comprises bioanalysis in drug development?

  It is the science of analysing biological samples to support the development of new drugs.
  
  - This is typically performed by commercial laboratories.
  - It is not standardized and has a low level of automation.
  
  
  (e.g. any new drug in development)

• What is qualitative bioanalysis?

  The question within this analysis is, what is present in the sample not the amount. The outcome will always be a specific name for example. So, it is the assessment of the identity of one or more of the components of a biological sample.

• What is quantitative bioanalysis?

  Here the question is the amount of a specific compound in a biological sample. So the answer will always be a specific amount of concentration.
  This means that it is the assessment of the concentrations of one or more of the components of a biological sample.

• What is regulated bioanalysis?

  This is bioanalysis that is performed according to scientific standards that are set by drug registration authorities. It is meant to ensure the reliability of the results.
  - It is necessary if you want to sell your drug in other countries for example.
  
  Key words: validation, quality control, precision, accuracy, selectivity and stability

• What is the difference between regulated bioanalysis and good laboratory practice (GLP)?

  GLP is a set of procedural guidelines issued by governments that are meant to ensure the integrity of results. This means that it is more focused on documentation, traceability, organization etc.
  
  - It is required for studies with animals but typically not for studies with humans.

• What is quality control?

  It takes place during the application of the method. Its purpose is to control the reliability of the bioanalytical method.