STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7

Unit 4: MRA 103T Regulatory affairs
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).

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 2

3. 1. INTRODUCTION 3

4. 1. INTRODUCTION 4

5. 2. PRINCIPLE OF E7 ICH GUIDELINE  5

6. 2. PRINCIPLE OF E7 ICH GUIDELINE 6

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 8

9. DEFINITION OF THE POPULATION  9

10. 4. CLINICAL EXPERIENCE  10

11. 4. CLINICAL EXPERIENCE  11

12. 5. Pharmacokinetic Studies 12

13. 5. Pharmacokinetic Studies  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) D rug 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   D rugs 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 17

18. 7. Drug-Drug Interaction Studies 18

19. 8. REFERENCE 19

20. THANK YOU! 20