FHD - pharmacology and Pharmaceuticals

contains FHD topics - Fundamentals of pharmacology and therapeutics, Pharmaceutical medicine roadshow ABPI seminar

What is pharmacology

the study of drugs

what is therapeutics

the treatment, knowledge and practical application of prescribing

what are the 6 prescribing rights

• right patient

• Right drug

• Right route

• Right dose

• Tight time 

• Right outcome

What word is used to descirbe what the drug does to the body

pharmacodynamics 

what word is used to describe what the body does to the drug

pharmacokinetics

what are common sites of drugs metabolism

liver, GI tract, lungs, skin

what does enzymic induction result in (in relation to metabolism)

faster metabolism 

what is first pass metabolism

the pathway the drug takes that results in only 20% reaching systemic circulation

what pathway do drugs take in first pass metabolism

swallowing, to digestive system, to hepatic portal system, to liver, to the rest of the body

why does only 20% of the drug end up in systemic circulation in first pass metabolism 

as drug is metabolised in GI tract and liver before reaching systemic circulation 

what is a pro drug

an active drug that generates an even more active metabolite after it has been metabolised

what are the three ways an injection can be given

Intravenously (IV), intramuscular (IM), subcutaneous (SC)

What does ADME stand for

absorption, distribution, metabolism, excretion

what does PK stand for

pharmacokinetics

what does NOAEL stand for 

no observed adverse effect level 

what do all new drugs need development in and what is the one exception to this rule

a paediatric population (unless granted a waiver)

What are the three stages of drug development

the discovery phase, launch phase, post launch

how long is the discovery phase

10-15 years 

What is the duration of the launch phase

5-10 years

how long is the post launch phase

20+

What is meant by two species toxicology and when is it carried out 

toxicology on one rodent and one non rodent, which is carried out in the non-clinical testing phase

What does the discovery phase of drug development involve

Finding potential new target medicines, non clinical studies, clinical studies, regulatory submission and pricing

how is the non rodent species in two species toxicology selected

based on if the drug binds to the same molecule that it will in humans

if the drug is only intended for single use, what should the duration of non-clinical testing be

14 days 

if the drug is intended for repeated use, what should the duration of the non clinical testing be

The same as the duration the human would have taken it for 

During clinical testing, what further non clinical testing is carried out

longer term toxicity studies, reproductive toxicity studies, carcinogenicity studies and specific studies

what determines the specific studies within non-clinical studies

the safety findings or findings from drugs of similar action

how many phases are involved in clinical testing 

4

in phase I of clinical testing who are the test subjects

health individuals

what is the duration of phase I of clinical studies

1-4 months

which phase of clinical studies tests for QT prolongation potential 

phase I

what is meant by QT prolongation potential

a drugs ability to lengthen the QT period

what is the QT period

the time taken for depolarisation and repolatrisation of the ventricle

what is the name given to the trials in phase I of clinical testing 

DDI

what does DDI trials stand for

drug drug interaction trials

what are DDI trials

where drugs are tested for their interactions with other drugs

what are the two categories a drug could fall into for a DDI trial 

victim or aggressor 

What is meant if the drug in a DDI trial is a victim

it is affected by the same drug pathway

what is meant if the drug in the DDI trial is an aggressor

it induces or inhibits the drug

how long are phase II clinical trials carried out for 

3-6 months

what is the name given to the trials carried out out in phase II

RCTs

what are RCTs

randomised clinical trials

what is the test group for phase II trials 

patients

what is the aim of the RCTs in phase II of clinical testing

to test or the effect of the test drug compared to a placebo or active control

what does Phase III of clinical testing consist of

two RCTs to test for dosage

what is the duration of phase III clinical trials 

1-3 years 

what does phase IV of clinical testing consist of

post marketing surveillance, paediatric studies

when does data exclusivity of a drug expire

8 years post licence grant

when does market exlusivity fo a dug expire 

2 years post data exclusivity 

when does a drug patent expire

20 years post formulation

what are the standards for non-biological generics

• non-clinical and clinical studies do not need to be repeated

• Once data exclusivity of originator is expired it can be cross referenced

• It must show PK bioequivalence to the originator

What are the standards for biological generics/ bio similar 

they must show efficacy in safety in phase III studies within the most sensitive patient population 

what are Go/ No-Go decisions

critical checkpoints to avoid wasted resources and to protect patients

what does SmPc stand for

Summary of product characterises

what is SmPc

a regulatory document with a guide to safety and prescribing 

what does PIL stand for

patient information leaflet

what is PIL

a simplified version of the SmPC for the patients 

what is the stats risk to the regulator in RCTs

Risk of approving ineffective drug

what is the stats risk to the sponsor in RCTs

stopping development of an effective drug

how can informed consent be improved 

via use of PIL and SmPC