Session 1

Question 1

What can inc risk of prescribing errors?

Answer 1

Question 2

What are slips?

Answer 2

Question 3

What is a lapse?

Answer 3

Either wasn’t concentrating or forget which led to error

Question 4

What are mistakes

Answer 4

Question 5

Answer 5

Defences, barriers and safeguards can all be penetrated!

Question 6

Before you write a prescription, confirm:

Answer 6

Question 7

Legal Requirements

Answer 7

Question 8

Requirements for a SAFE prescription

Answer 8

Question 9

What should be reported?

Answer 9

1. • Black triangle drugs & unlicensed herbal preparations – report all suspected reactions, however trivial the reaction

• Established products and vaccines – report all suspected serious reactions, even if the reaction is well- known and recognised
• All paediatric reactions

Question 10

What is a black triangle drug?

Answer 10

• one which is being intensively monitored
• generally one which has been

– newly released

– changed indications

– changed formulations

– combination product

Question 11

What is a serious reaction?

Answer 11

• Any reaction which results in or prolongs hospitalisation
• Serious reactions also include those that are

– fatal

– life-threatening

– disabling

– incapacitating

Question 12

What are the stages in drug developement?

Answer 12

Question 13

High Throughput Screening

1. What is it?
2. It is high throughput and automated as?
3. What do we question in HITs?

Answer 13

1. automated approaches to screening candidate compounds for pharmaceutical development (screens drugs from research which can be further developed)
2. most compound banks that are screened contain greater than 500,000 compounds
3.  Is it the correct structure?
    Is it chemically stable?
    Is it selective for the target screen?
    Is it novel?

Question 14

Lead Identification : turning the hit into a lead

1. Questions we contemplate

Answer 14

 Does it have the correct physical properties?

 Can we resolve any ADME issues?

 Can analogues be easily synthesised using robotic and parallel synthesis?

 Can the potency be improved with variation in structure?

Question 15

Lead Optimisation : turning the lead into a Candidate Drug

How do we turn the lead into a candidate drug?

Answer 15

Increase potency

 Active at receptor at concentrations < 1 X 10-8 M

 Can be administered in a reasonably sized tablet !

Optimise selectivity

 No unwanted pharmacological activities, side effects

Optimise physical properties & pharmacokinetics

 Tablet taken once or twice daily

 Must be absorbed, retained and stable to metabolism

Ensure efficacy in disease models

 Gives confidence for efficacy in man

Question 16

Disease Rationale Example Finding a “drug-able” Molecular Target for COPD

Answer 16

Question 17

An Outline Programme for Toxicology

Answer 17

Question 18

1. Key questions we must act for each phase
2. Phase 1

Answer 18

1. • Can it work ?
   – Proof of Principle (PoP) studies Phase 1/IIa
   • Does it work ?
   – Proof of Concept (PoC) studies Phase IIb/III – Dose range finding
   • Is it worth it anyway ?
   – Pharmacoenconomics
   – Post-marketing surveillance Phase III/IV – Safety Phase I-IV

2.• First into Man (RITM) – SAD / MAD
• Small number of healthy volunteers
• Regulatory approval required
• Ethical approval required
• Investigates pharmaco-kinetics and evaluates safety