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E7 -STUDIES IN SUPPORT OF GENERAL
POPULATIONS: GERIATRICS
PRESENTED BY:
SHRUTI JAGIRDAR
2308212170004
1
GUIDED BY:
PUJA BHAVSAR
ASSISTANT
PROFESSIOR
PARUL INSTITUTE OF PHARMACY
PARUL UNIVERSITY
LIMDA, VADODARA
CONTENT
• INTRODUCTION
• PRINCIPLE
• CLINICAL EXPERIENCE
• PHARMACOKINETIC STUDIES
• PHARMACODYAMIC
• DRUG-DRUG INTERACTION STUIDES
• REFRENCE
2
1. INTRODUCTION
International Council for Harmonization (ICH) is a Technical Requirements
for Pharmaceuticals for Human Use.
ICH Guidelines on technical requirements on:
1. Safety
2. Quality
3. Efficacy
4. Multidisciplinary
The goal of ICH to promote international harmonization by bringing together
representative from the three ICH regions (EU, Japan, USA) to discuss and
establish common guidelines.
3
1. INTRODUCTION
4
ICH's mission is to achieve greater harmonisation worldwide to
ensure that safe, effective, and high quality medicines are
developed and registered in the most resource-efficient manner.
The ICH guidance E7 provides recommendations on special
considerations that apply in the design and conduct of clinical
trials of medicines that are likely to have significant use in the
elderly.
2. PRINCIPLE OF E7 ICH GUIDELINE
5
E7 -Studies In Support of General
Populations: Geriatrics
• It is important to ensure that clinical testing
programs are carried out according to harmonised
guidelines based on agreed ethical and scientific
principles.
• Harmonisation in relation to medicines for geriatric
populations is an important issue because the total
population of the elderly will increase significantly
in the coming years in Europe, Japan and the USA.
2. PRINCIPLE OF E7 ICH GUIDELINE
6
Drugs should be studied in all age groups, including the elderly, for
which they will have significant utility. Patients entering clinical
trials should be reasonably representative of the population that
will be later treated by the drug.
The use of drugs in this population requires special consideration
due to the frequent occurrence of underlying diseases, concomitant
drug therapy and the consequent risk of drug interaction.
3. SCOPE OF GUIDELINE
 This guideline is directed principally toward new
Molecular Entities that are likely to have significant use
in the elderly, either because the disease intended to be
treated is characteristically a disease of aging (e.g.,
Alzheimer's disease) or because the population to be
treated is known to include substantial numbers of
geriatric patients(e.g., hypertension).
7
3. SCOPE OF GUIDELINE
It likewise applies when the new formulation or new
combination is likely to alter the geriatric patient's
response (with regard to either safety/ tolerability or
efficacy) compared with that of the non-geriatric patient
in a way different from previous formulations.
The guideline also applies to new uses that have
significant potential applicability to the elderly.
8
DEFINITION OF THE POPULATION
The geriatric population is arbitrarily defined, for the
purpose of this guideline, as comprising patients aged
65 years or older. It is important, however, to seek
patients in the older age range, 75 and above, to the
extent possible.
It is also important not to exclude unnecessarily
patients with concomitant illnesses; it is only
by observing such patients that drug-disease
interactions can be detected.
9
4. CLINICAL EXPERIENCE
Geriatric patients should be included in the Phase 3 database (and
in Phase 2, at the sponsor's option) in meaningful numbers. The
geriatric subpopulation should be represented sufficiently to
permit the comparison of drug response in them to that of younger
patients.
For drugs used in diseases not unique to, but present in, the elderly
a minimum of 100 patients would usually allow detection of
clinically important differences. For drugs to treat relatively
uncommon diseases, smaller numbers of the elderly would be
expected.
10
4. CLINICAL EXPERIENCE
Where the disease to be treated is characteristically
associated with aging (e.g., Alzheimer's disease) it is
expected that geriatric patients will constitute the major
portion of the clinical database.
The overall database of the dossier should be examined for
the presence of age related differences, e.g., in adverse
event rates, in effectiveness, and in dose response. If these
relatively crude overview analyses show important
differences, further evaluation may be needed.
11
5. Pharmacokinetic Studies
Most of the recognized important differences between
younger and older patients have been pharmacokinetic
differences, often related to impairment of excretory
(renal or hepatic) function or to drug-drug interactions.
It is important to determine whether or not the
pharmacokinetic behavior of the drug in elderly subjects
or patients is different from that in younger adults and to
characterize the effects of influences, such as abnormal
renal or hepatic function, that are more common in the
elderly even though they can occur in any age group.
12
5. Pharmacokinetic Studies
Information regarding age-related differences in the
pharmacokinetics of the drug can come, at the sponsor's
option with these studies are examined:
1. Pharmacokinetic Screen Approach
2. Formal pharmacokinetic studies,
3. Pharmacokinetics in Renally or Hepatically Impaired
Patients
13
5. Pharmacokinetic Studies
Pharmacokinetic
studies
Medication
provided
No. of
subjects
PK Evaluation
1. Formal
pharmacokinetic
studies
Steady state
condition
single dose
Multiple dose
Small No.
of subjects
Large No.
of subjects
Small No.
of subjects
To permit statistical comparisons
between geriatric and younger
subjects' or patients'
pharmacokinetic profiles is also
acceptable.
2. Pharmacokinetic
Screen Approach
Steady state
condition
Small No.
of subjects
(1 or 2)
Drug blood level determinations
at "trough" (i.e., just prior to the
next dose) or other defined times
from sufficient numbers of Phase
2/3 clinical trials patients,
geriatric and younger, to detect
age-associated differences in
pharmacokinetic behavior.
14
5. Pharmacokinetic Studies
3.Pharmacokinetics
in Renally or
Hepatically
Impaired Patients.
- Small No. of
subjects
Drugs excreted
(parent drug or
active metabolites)
significantly
through renal
mechanisms should
be studied to define
the effects of
altered renal
function on their
pharmacokinetics.
15
6. PHARMACODYNAMIC or DOSE
RESPONSE STUDIES
 The number of age-related pharmacodynamic differences
(i.e., increased or decreased therapeutic response, or side
effects, at a given plasma concentration of drug) discovered
to date is too small to necessitate dose response or other
pharmacodynamic studies in geriatric patients as a routine
requirement.
 Separate studies are, however, recommended in the
following situations:
1. Sedative/hypnotic agents and other psychoactive drugs or
drugs with important CNS effects, such as sedating
antihistamines
2. Where subgroup comparisons (geriatric versus younger)
in the Phase 2/3 clinical trials database
16
7. Drug-Drug Interaction
Studies
Such interactions are of particular importance to geriatric
patients, who are more likely to be using concomitant
medications than younger patients, but of course are not limited
to this age group.
The studies needed must be determined case by-case, but the
following are ordinarily recommended:
Digoxin and oral anticoagulant interaction studies, because so
many drugs alter serum concentrations of these drugs, they are
widely prescribed in the elderly, and they have narrow
therapeutic ranges
17
7. Drug-Drug Interaction
Studies
18
For drugs that undergo extensive hepatic
metabolism, determination of the effects of
hepatic-enzyme inducers (e.g., phenobarbital)
and inhibitors (e.g., cimetidine)
Interaction studies with other drugs that are
likely to be used with the test drug (unless
important interactions have been ruled out by a
Pharmacokinetic Screen)
8. REFERENCE
https://www.ich.org/
https://database.ich.org/sites/default/files/E7_Guideline.pdf
https://www.slideshare.net/mdgayas70/ich-guidelines-
seminar
https://admin.ich.org/sites/default/files/2023-
07/OverviewOfICH_2023_0619.pdf
19
THANK YOU!
20

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STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7

  • 1. E7 -STUDIES IN SUPPORT OF GENERAL POPULATIONS: GERIATRICS PRESENTED BY: SHRUTI JAGIRDAR 2308212170004 1 GUIDED BY: PUJA BHAVSAR ASSISTANT PROFESSIOR PARUL INSTITUTE OF PHARMACY PARUL UNIVERSITY LIMDA, VADODARA
  • 2. CONTENT • INTRODUCTION • PRINCIPLE • CLINICAL EXPERIENCE • PHARMACOKINETIC STUDIES • PHARMACODYAMIC • DRUG-DRUG INTERACTION STUIDES • REFRENCE 2
  • 3. 1. INTRODUCTION International Council for Harmonization (ICH) is a Technical Requirements for Pharmaceuticals for Human Use. ICH Guidelines on technical requirements on: 1. Safety 2. Quality 3. Efficacy 4. Multidisciplinary The goal of ICH to promote international harmonization by bringing together representative from the three ICH regions (EU, Japan, USA) to discuss and establish common guidelines. 3
  • 4. 1. INTRODUCTION 4 ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The ICH guidance E7 provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly.
  • 5. 2. PRINCIPLE OF E7 ICH GUIDELINE 5 E7 -Studies In Support of General Populations: Geriatrics • It is important to ensure that clinical testing programs are carried out according to harmonised guidelines based on agreed ethical and scientific principles. • Harmonisation in relation to medicines for geriatric populations is an important issue because the total population of the elderly will increase significantly in the coming years in Europe, Japan and the USA.
  • 6. 2. PRINCIPLE OF E7 ICH GUIDELINE 6 Drugs should be studied in all age groups, including the elderly, for which they will have significant utility. Patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug. The use of drugs in this population requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.
  • 7. 3. SCOPE OF GUIDELINE  This guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is characteristically a disease of aging (e.g., Alzheimer's disease) or because the population to be treated is known to include substantial numbers of geriatric patients(e.g., hypertension). 7
  • 8. 3. SCOPE OF GUIDELINE It likewise applies when the new formulation or new combination is likely to alter the geriatric patient's response (with regard to either safety/ tolerability or efficacy) compared with that of the non-geriatric patient in a way different from previous formulations. The guideline also applies to new uses that have significant potential applicability to the elderly. 8
  • 9. DEFINITION OF THE POPULATION The geriatric population is arbitrarily defined, for the purpose of this guideline, as comprising patients aged 65 years or older. It is important, however, to seek patients in the older age range, 75 and above, to the extent possible. It is also important not to exclude unnecessarily patients with concomitant illnesses; it is only by observing such patients that drug-disease interactions can be detected. 9
  • 10. 4. CLINICAL EXPERIENCE Geriatric patients should be included in the Phase 3 database (and in Phase 2, at the sponsor's option) in meaningful numbers. The geriatric subpopulation should be represented sufficiently to permit the comparison of drug response in them to that of younger patients. For drugs used in diseases not unique to, but present in, the elderly a minimum of 100 patients would usually allow detection of clinically important differences. For drugs to treat relatively uncommon diseases, smaller numbers of the elderly would be expected. 10
  • 11. 4. CLINICAL EXPERIENCE Where the disease to be treated is characteristically associated with aging (e.g., Alzheimer's disease) it is expected that geriatric patients will constitute the major portion of the clinical database. The overall database of the dossier should be examined for the presence of age related differences, e.g., in adverse event rates, in effectiveness, and in dose response. If these relatively crude overview analyses show important differences, further evaluation may be needed. 11
  • 12. 5. Pharmacokinetic Studies Most of the recognized important differences between younger and older patients have been pharmacokinetic differences, often related to impairment of excretory (renal or hepatic) function or to drug-drug interactions. It is important to determine whether or not the pharmacokinetic behavior of the drug in elderly subjects or patients is different from that in younger adults and to characterize the effects of influences, such as abnormal renal or hepatic function, that are more common in the elderly even though they can occur in any age group. 12
  • 13. 5. Pharmacokinetic Studies Information regarding age-related differences in the pharmacokinetics of the drug can come, at the sponsor's option with these studies are examined: 1. Pharmacokinetic Screen Approach 2. Formal pharmacokinetic studies, 3. Pharmacokinetics in Renally or Hepatically Impaired Patients 13
  • 14. 5. Pharmacokinetic Studies Pharmacokinetic studies Medication provided No. of subjects PK Evaluation 1. Formal pharmacokinetic studies Steady state condition single dose Multiple dose Small No. of subjects Large No. of subjects Small No. of subjects To permit statistical comparisons between geriatric and younger subjects' or patients' pharmacokinetic profiles is also acceptable. 2. Pharmacokinetic Screen Approach Steady state condition Small No. of subjects (1 or 2) Drug blood level determinations at "trough" (i.e., just prior to the next dose) or other defined times from sufficient numbers of Phase 2/3 clinical trials patients, geriatric and younger, to detect age-associated differences in pharmacokinetic behavior. 14
  • 15. 5. Pharmacokinetic Studies 3.Pharmacokinetics in Renally or Hepatically Impaired Patients. - Small No. of subjects Drugs excreted (parent drug or active metabolites) significantly through renal mechanisms should be studied to define the effects of altered renal function on their pharmacokinetics. 15
  • 16. 6. PHARMACODYNAMIC or DOSE RESPONSE STUDIES  The number of age-related pharmacodynamic differences (i.e., increased or decreased therapeutic response, or side effects, at a given plasma concentration of drug) discovered to date is too small to necessitate dose response or other pharmacodynamic studies in geriatric patients as a routine requirement.  Separate studies are, however, recommended in the following situations: 1. Sedative/hypnotic agents and other psychoactive drugs or drugs with important CNS effects, such as sedating antihistamines 2. Where subgroup comparisons (geriatric versus younger) in the Phase 2/3 clinical trials database 16
  • 17. 7. Drug-Drug Interaction Studies Such interactions are of particular importance to geriatric patients, who are more likely to be using concomitant medications than younger patients, but of course are not limited to this age group. The studies needed must be determined case by-case, but the following are ordinarily recommended: Digoxin and oral anticoagulant interaction studies, because so many drugs alter serum concentrations of these drugs, they are widely prescribed in the elderly, and they have narrow therapeutic ranges 17
  • 18. 7. Drug-Drug Interaction Studies 18 For drugs that undergo extensive hepatic metabolism, determination of the effects of hepatic-enzyme inducers (e.g., phenobarbital) and inhibitors (e.g., cimetidine) Interaction studies with other drugs that are likely to be used with the test drug (unless important interactions have been ruled out by a Pharmacokinetic Screen)