Cder ind nda reviews guidance the common technical document and good review practice
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CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice. John K. Leighton, Ph.D., DABT CDER/FDA. Overview. Current IND/NDA review process FDA/ICH guidance Common Technical Document CDER Pharmacology Good Review Practice. Review Team. Project Managers

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CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice

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Cder ind nda reviews guidance the common technical document and good review practice

CDER IND/NDA ReviewsGuidance, The Common Technical Document and Good Review Practice

John K. Leighton, Ph.D., DABT

CDER/FDA


Overview

Overview

  • Current IND/NDA review process

  • FDA/ICH guidance

  • Common Technical Document

  • CDER Pharmacology Good Review Practice


Review team

Review Team

Project Managers

Medical Officers

Pharmacologists/Toxicologists

Chemists

Pharmacokineticists

Statisticians


Nonclinical studies

Nonclinical Studies

  • Pharmacodynamics/Pharmacology

  • Pharmacokinetics

  • Safety pharmacology

  • Toxicology

  • Genetic toxicity

  • Reproductive toxicity

  • Carcinogenicity


Goals of nonclinical ind studies

Goals of Nonclinical IND Studies

  • Identify starting dose

  • Identify organ toxicities and reversibility

  • Guide dosing regimens and escalation schemes


Pharmacology studies

Pharmacology Studies

  • Pharmacological activity determined in nonclinical studies is generally of low relevance to safety (IND) and efficacy (NDA) decisions.

  • Summary report,without individual animal records or individual study results, usually suffices.


Toxicology study design

Toxicology Study Design

  • Pivotal for safety/start dose decision.

  • Toxicology studies should mimic the schedule, duration, formulation, and route as that proposed for the clinical trial.

  • Conform to standard toxicology protocols.

  • Conduct according to GLP.


Initial ind development

Initial IND Development

  • Integrated pharmacology/toxicology summary.

  • Full tabulation of each toxicology study to support safety of proposed trial.

  • Pharmacogenomic data:

    • Start dose selection?

    • Choice of relevant species?

    • Identify biomarkers?


Ind nda stage

IND/NDA Stage

  • Long-term toxicology studies

  • Genetic toxicology panel completed

  • Reproductive toxicology

  • Carcinogenicity studies (if necessary)

  • Pharmacogenomic data:

    • Decrease study length?

    • Improve assessment of organ toxicity?

    • Provide mechanistic explanation of toxicity?

      Not replace standard assessment


Guidance fda ich

GuidanceFDA/ICH

  • Represent current thinking of the Agency.

  • Recommendations/not requirements.

  • FDA Guidance

    • Draft (for comment purposes only)

    • Final

  • http://www.fda.gov/cder/guidance/index.htm


Fda ich guidance topics

IND format

Start dose selection

Acute toxicity testing

Electronic NDA submission

Carcinogenicity

Genetic toxicity

Reproductive toxicity

Photosafety testing

Immunotoxicology

Biotechnology

FDA/ICH Guidance Topics


The common technical document

The Common Technical Document

  • Guidance describing harmonized format for technical documentation for registration in all three regions.

    • Modules 2-5 common to all regions

    • Reduces time and resources used to compile registration documentation

  • Use with other ICH and Agency guidance.

  • Allows for regional specific summaries.


Good review practice

Good Review Practice

  • Guidance for Reviewers: Pharmacology/Toxicology Review Format

  • Internal review format for IND and NDA primary reviews

  • Purpose

    • standardization of reviews across divisions

    • ensure that important information is captured

    • allows for continued assessment of IND

  • Consistent with ICH CTD

  • http://www.fda.gov/cder/guidance/4120fnl.pdf


Good review practice general toxicology study

Good Review PracticeGeneral Toxicology Study

Results:Mortality

Clinical Signs

Body Weights

Food Consumption

Ophthalmoscopy

Electrocardiography

Hematology

Clinical Chemistry

Urinalysis

Organ Weights

Gross Pathology

Histopathology

Toxicokinetics


Summary

SUMMARY

  • Different submission format for pivotal safety data.

  • Good review practices for evaluation of data; provides consistency among review divisions and transparency. GRP will need to consider interdiscliplinary review of pharmacogenomic data.

  • Pharmacogenomics may play an important role in safety assessment in future INDs and NDAs.


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