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Drug discovery, testing and publication

Infection and response • Communicable diseases

Key concepts

What you'll likely be quizzed about

  • Drug development begins with computer modeling to prioritize candidate compounds.
  • Laboratory testing frequently involves cultured cells and tissues to observe biological effects.
  • Effective candidates progress to preclinical animal studies for safety and dosing assessment before human testing begins.
  • Clinical trials determine toxicity, efficacy, and dosing, after which regulatory bodies license safe and effective medicines for manufacture and sale.
  • Each stage of the process is time-intensive and costly, with many candidates failing to progress.

Flashcards

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Why is peer review important before publishing trial results?

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Peer review checks methods and data for errors, bias, or false claims before publication.

Key notes

Important points to keep in mind

Computer modeling and laboratory tests reduce the number of compounds before animal testing.

Preclinical tests involve cells, tissues, and live animals; animal data may not predict human reactions.

Phase 1 tests safety and dosing in healthy volunteers; later phases measure efficacy in patients.

Double-blind, placebo-controlled design limits bias and reveals true drug effects.

Peer review occurs before publication to check for errors and false claims.

Many critical drugs originate from natural sources: penicillin (mould), aspirin (willow), digitalis (foxglove).

Dose limits and ethical safeguards protect trial participants; rules exist for participant safety.

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