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
3
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller annamelbourne. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $5.97. You're not tied to anything after your purchase.
