Revision notes for pharmacy degree modules that involve drug design and development - these notes have been based on learning material from Cardiff University's MPharm module Molecule to Patient (PH1121)
MOLECULE TO PATIENT REVISION ............................................................................................................... 1
DRUG DEVELOPMENT KEY PHASES .............................................................................................................................1
DRUG TARGETS.......................................................................................................................................................2
OSTEOPOROSIS .......................................................................................................................................................4
DRUG DESIGN ........................................................................................................................................................5
OPTIMISATION OF DRUGS .........................................................................................................................................8
ETHICAL CONSIDERATIONS ......................................................................................................................................12
BIOLOGICAL DRUG PRODUCTS .................................................................................................................................14
DRUG DELIVERY SYSTEMS .......................................................................................................................................21
PHARMACODYNAMICS............................................................................................................................................30
PHARMACOKINETICS ..............................................................................................................................................30
BIOLOGICAL BARRIERS ............................................................................................................................................33
FIRST ORDER KINETICS: ..........................................................................................................................................36
ZERO ORDER KINETICS: ..........................................................................................................................................36
HALF LIFE: ...........................................................................................................................................................37
DISTRIBUTION AND ELIMINATION .............................................................................................................................37
HEPATIC ELIMINATION: ..........................................................................................................................................39
KIDNEY AND EXCRETION: ........................................................................................................................................40
CLINICAL GOVERNANCE AND GXP ............................................................................................................................42
CLINICAL TRIALS ....................................................................................................................................................47
POST MARKETING SURVEILLANCE .............................................................................................................................52
HEALTH PSYCHOLOGY ............................................................................................................................................55
MARKETING MEDICINES AND NICE ..........................................................................................................................57
REGULATORY BODIES & PROCESSES..........................................................................................................................61
Drug Development Key Phases
- Discovery:
o Identify area of unmet need
o Find target
o Screen compounds to identify a lead compound
- Development:
o In vitro (controlled environment) tests
o In vivo tests (plant, animal, person)
o Pharmacokinetics (ADME)
o Pharmacodynamics
, o Toxicology/toxicity
o DD tests
o Many cycles of optimisation
o GLP
- Clinical Trials:
o Human subjects
o Safety, effectiveness, comparisons
o Phase 1 = safety in healthy people, phase 2 = safety and
effectiveness in disease group, phase 3 = effectiveness in
larger group
o GCP + regulatory bodies
- Manufacture and marketing:
o Scale-up for clinical trials
o GMP/cGMP
o Audit trail
o Consistent manufacture of effective drug
o Appropriate marketing
o Post marketing surveillance
Drug Targets
Good drug targets share several crucial features:
- Involved in crucial biological (disease pathway)
- Distinction from any previously known target
- Functionally and structurally characterised
- Druggable (capable of binding to small molecules)
First, we need to understand the disease pathway to understand what
might represent a therapeutic target – causative vs correlative drug
targets.
Disease can be defined at varying levels: symptomatic,
pathological/systematic, cellular, molecular
2
, Types of drug target: proteins (enzymes, receptors, channels, etc.),
carbohydrates/lipids, DNA/genes]
Target Identification Strategies:
- Gene expression profiling (genomics)
- Protein expression profiling (proteomics)
- Compare gene/protein expression identification – disease vs non
disease models
- Techniques: gene/protein microarray, mass spec
Target Validation:
- Proof that gene/protein of interest plays a fundamental role in the
disease pathway
- Approaches used:
o Gene/protein overexpression studies
▪ Increase expression of gene/protein in healthy
animal/normal cells – look at change in phenotype
o Gene/protein inhibition studies
▪ Decrease protein expression in animal models of
disease or appropriate cell lines – look at whether
disease phenotype is altered
Summary
- Certain properties make molecular elements more suitable as drug
targets
- Understanding disease at a molecular level helps identify potential
drug targets
- Identification of drug targets requires an appropriate method
- Need to validate potential drug targets
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