Lecture 2 Flashcards
* main stages of drug discovery and development * Overview of major body systems affected
Rationale Drug Design
Validated biological Targetversus Drug(that optimally interacts with the target) Triggering of desired biological action
Receptor-based drug design
3D structure analysis of biological target
Pharmacophore-based drug design
Structures of known active small molecules
Main stages of drug discovery and development.
Drug Discovery, Preclinical Development Phase, Clinical Development Phase
Drug Discovery
Identification of candidate molecules on their pharmacological, biochemical and physicochemical properties.
Preclinical development
Non-human studies to determine basic pharmacokinetics, potential toxic side effects and formulation.
Clinical Development
Determination of efficacy, side effects and optimum dosage in volunteers and patients.
Describe (i) of Drug Development
(a). Chemical or biochemical synthesis of novel compound.
(b). Isolation of active ingredient from natural source
(c). Production and isolation of Biologicals
(ii) of Drug Development
Pre-clinical testing 1: effects of drug on cellular function
(iii) Drug Development
Pre-clinical testing 2: Mechanism of drug action
(iv) of Drug Development
Pre-clinical testing 3: Toxicity testing (in vivo & in vitro & ex vivo)
(v) of Drug Development
Phase 0 - human micro dosing. Pharmacokinetic profile of extremely low, non-pharmacological drug doses.
(vi) Drug Development
(vi) Phase 1 - clinical trial : on healthy subjects
Effects on body functions; drug safety
(vii) Drug Development
(vii) Phase 2 - clinical trial: on selected patients
(viii) Drug Development
(viii) Phase 3 - clinical trial: on large groups of patients
- Comparision to other therapies
