SLIDE 1
Frequent approaches in the Clinical setting Extrapolation across
- Patients
- Products
- Pathologies
W hen do clinicians usually extrapolate in their practice? Daniel - - PowerPoint PPT Presentation
W hen do clinicians usually extrapolate in their practice? Daniel - - PowerPoint PPT Presentation
W hen do clinicians usually extrapolate in their practice? Daniel Brasseur CHMP Christoph Male PDCO Frequent approaches in the Clinical setting Extrapolation across Patients Products Pathologies Patients Sam e m edicine than in
SLIDE 2
SLIDE 3
3
Sam e m edicine than in adults used ‘dow n the age’
1 / dow n/ up the age class
Patients
SLIDE 4
SLIDE 5
5
‘dow n the age’ How Far can w e go ?
Patients
SLIDE 6
Morphology? Function?
SLIDE 7
7
‘Up the age’
Cystic fibrosis Congenital disorders (orphan conditions) …
Patients
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8
‘Up and dow n again…’
Cystic fibrosis Congenital disorders (orphan conditions) …
Patients
SLIDE 9
Frequent approaches in the Clinical setting Extrapolation across
- Patients
- Products
- Pathologies
SLIDE 10
10
Different m edicines belonging to a class
- Drug/ pro-drug
( [ des] loratadine...)
- Bio-equivalence
( Release form ulation, conversion factor)
- Therapeutic equivalence
( anti-TNF in MS, Blood factor substitution, ERT) ( vaccines, based on sero-conversion factors) ( one statine to another, m onitored by LDL-Chol) )
- Me-too, is not equi-potency
( for E [ long term effect statines] &/ or S...)
Products
SLIDE 11
Frequent approaches in the Clinical setting Extrapolation across
- Patients
- Products
- Pathologies
SLIDE 12
12
Sam e products used for different diseases
- pain / fever
- leukaem ia/ lym phom a
- arthritis…
- HTA [ prim ary,secondary]/ heart failure
- Allergy/ exercise induced asthm a
- Heart failure stage I ,I I ,I I I ,I V
- Cancer stage, relapse...
Pathologies
SLIDE 13
13
Sam e product but used in different diseases
WEST
10 years 2 years 1 month
EI EE EME
IDIOPATHIC NON IDIOPATHIC FOCAL GENERALISED
JME Childhood Absence epilepsy Reading epilepsy Epilepsy with CT spikes Dravet syndrome Adolescent absence epilepsy Epilepsy with GTCS
- n
awakening Symptomatic or cryptogenic focal epilepsies
- E. partialis
continua Acquired epileptic Aphasia Epilepsy with CSWS
- E. With
myoclonic absences Doose syndrome Lennox Gastaut syndrome BMEI BFNS BNS
Sylvie N'Guyen
BIFS BIS
MPSI
epsy
Pathologies
SLIDE 14
How do Clinicians behave?
I nterlinking
- Mechanism of action of the disease
( pathogenesis/ pathw ays)
- Mechanism of action of the drug
( target, receptors)
- Clinical condition/ presentation