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Clinical approach
« Extrapolation refers to the use of an
em pirical rule
- utside its field of validation »
W hen do clinicians usually extrapolate in their practice? Clinical - - PowerPoint PPT Presentation
W hen do clinicians usually extrapolate in their practice? Clinical - - PowerPoint PPT Presentation
W hen do clinicians usually extrapolate in their practice? Clinical approach Extrapolation refers to the use of an em pirical rule outside its field of validation Frequent Extrapolation approaches in Clinical setting 1 / dow n/
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Frequent Extrapolation approaches in Clinical setting
1 / ‘dow n/ up’ the age class 2 / betw een m edicines belonging to a class 3 / from one disease to another, from one stage/ line to another
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Frequent Extrapolation approaches in Clinical setting
1 / dow n/ up the age class
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Frequent Extrapolation approaches in Clinical setting
1 / dow n/ up the age class
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Rare Extrapolation approaches in Clinical setting
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Rare Extrapolation approaches in Clinical setting
Cystic fibrosis Congenital disorders (orphan conditions) …
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Rare Extrapolation approaches in Clinical setting
Cystic fibrosis Congenital disorders (orphan conditions) …
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Presentation title (to edit, click View > Header and Footer) 9
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1 / sam e m edicine ‘dow n/ up’ the age classes
- Facing sam e disease ?
&
- Bio-availability is sim ilar
- PK is linear
- Dose response is sim ilar ( PD)
- r...
10 years 2 years 1 month
EI EE EMEIDIOPATHIC NON IDIOPATHIC FOCAL GENERALISED
JME Childhood Absence epilepsy Reading epilepsy Epilepsy with CT spikes Dravet syndrome Adolescent absence epilepsy Epilepsy with GTCS- n
- E. partialis
- E. With
Sylvie N'Guyen
BIFS BISMPSI
epsy
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1 / sam e m edicine dow n/ up the age class m ore robust at hand of a surrogate m arker of efficacy ( not necessarily safety) Vaccine
HPV antibody response
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Age at Enrollment (Years)
500 700 900 1100 1300 1600
Anti-HPV 6 GMTs
Efficacy Program Immunogenicity Bridge
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1 / sam e m edicine ‘dow n/ up’ the age class
- r targeting an ‘external’ pathogen
Antibiotics in... CAP I CU ResistP
‘
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2 / betw een different m edicines belonging to a sam e class used for a specific disease
- 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...)
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3 / sam e m edicine from one disease/ sym ptom to a sim ilar, from one stage to another
- 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...
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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
( individual sign & sym ptom s)
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W ithin sam e ‘nosological’ entity
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Across sam e ‘pathological pathw ays’
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CHMP
COMP PDCO PDCO
Indication Designation
MoA
Product Disease Conditions
Clinicians
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Summary
Extrapolation in use based on Clinical intuition
- Signs & symptons (presentation)
- Knowledge of the disease (pathogenicity)
- Mechanism of action drug (target)
- Personal experience (off-label)
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