Good practice for introducing radiopharmaceuticals for clinical use.

Format:

Book

Series:

IAEA-TECDOC ; 1782.

IAEA TECDOC Series, 1011-4289 ; 1782

Language:

English

Subjects (All):

Radiopharmaceuticals.

Radioisotopes in medical diagnosis.

Physical Description:

1 online resource (72 pages) : illustrations, tables.

Edition:

1st ed.

Place of Publication:

Vienna, Austria : International Atomic Energy Agency, 2016.

Summary:

The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases - information that often times cannot be obtained by other means. However, there is a perceived need in many Member States for a useful reference to facilitate and expedite the introduction of radiopharmaceuticals already in clinical use in other countries. This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product is administered to the patient at all times.

Contents:

Intro

1. Introduction

1.1. BACKGROUND

1.2. OBJECTIVE

1.3. SCOPE

2. New Radiopharmaceuticals

2.1. NEW PET/SPECT RADIOPHARMACEUTICALS FOR CLINICAL USE

2.2. BEST AVAILABLE IMAGING METHOD

2.3. QUALITY ASSURANCE

2.4. TIME AND COST EFFECTIVENESS OF REPLICATION STUDIES

2.5. KEY COMPONENTS

2.5.1. Clinical usefulness

2.5.2. Demographic considerations

2.5.3. Reimbursement for the diagnostic procedure

2.5.4. Enthusiasm of referring physicians for the service

2.5.5. Sufficient imaging and reporting resources

2.5.6. Clinical lead/driver

2.5.7. Adequate GMP compliant facility

3. STEPS TOWARDs the INTRODUCTION OF RADIOPHARMACEUTICALs

3.1. GENERAL RADIOPHARMACEUTICAL IMPLEMENTATION SCHEMA

3.1.1. Identify radiopharmaceutical

3.1.2. Literature search

3.1.3. Formulate questions/proposal for regulators

3.1.4. Identify synthesis process for radiopharmaceutical

3.1.5. Prepare a submission package for regulatory submission

3.1.6. Confirm plan with regulators

3.1.7. Obtain financial resources

3.1.8. Validate manufacture process

3.1.9. Submit a dossier to regulators

3.1.10. Identify and validate sites (if confirmatory trial needed)

3.1.11. Initiate trial and analyze data (if confirmatory trial needed)

3.1.12. Formulate and submit final results

3.1.13. Receive regulatory approval

3.2. FLOW CHART

4. IDENTIFICATION AND EVALUATION OF DATA

4.1. IDENTIFICATION

4.2. EVALUATION OF EXISTING DATA OF MEDICAL USEFULNESS

4.3. POSSIBLE PARTNERSHIP

4.4. REGULATORY AUTHORITIES

4.5. RADIOPHARMACEUTICALS NOT INCLUDED IN PHARMACOPOEIA

4.6. GOOD MANUFACTURING PRACTICE

4.7. RISK MANAGEMENT

4.8. MEDICAL ISSUES

4.8.1. Definition of clinical indication

4.8.2. Imaging requirements

4.8.3. Personnel training.

4.8.4. Education and informing referring physician

4.9. MAGISTRAL AND OFFICINAL PREPARATIONS

4.10. POTENTIAL LIMITATIONS

4.11. CONCLUSIONS

5. INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER

5.1. INTRODUCTION

5.2. CHEMICAL PHARMACEUTICAL AND BIOLOGICAL DATA

5.2.1. Drug substance

5.2.1.1. General information

Nomenclature

Structure

General properties

5.3. MANUFACTURE

5.3.1.1. Manufacturer(s)

5.4. DESCRIPTION OF MANUFACTURING PROCESS AND PROCESS CONTROLS

5.4.1. Synthetic route

5.4.2. Synthetic route for batches used in nonclinical studies

5.4.3. Control of materials

5.4.4. Controls of critical steps and intermediates

5.4.5. Process validation and/or evaluation

5.4.6. Manufacturing process development

5.4.7. Elucidation of structure and other characteristics

5.4.8. Impurities

5.4.8.1. Potential impurities from the synthesis and degradation of [18F]NaF injection

5.4.8.2. Potential impurities which may arise during irradiation

5.4.9. Control of drug substance

5.4.9.1. Specification

5.4.9.2. Analytical procedures

5.4.9.3. Description of [18F]NaF injection

5.4.9.4. Identification of [18F]NaF injection by -HPLC

5.4.9.5. [18F]NaF injection content by HPLC

5.4.9.6. Radiochemical impurities content of [18F]NaF injection by HPLC

5.4.9.7. Validation of analytical procedures

5.4.9.8. [18F]NaF injection content by HPLC

5.4.9.9. Radiochemical impurities content of [18F]NaF injection by HPLC

5.4.9.10. Batch analysis

5.4.9.11. Reference standards or materials

5.4.9.12. Container closure system

5.4.10. Stability

5.4.10.1. Decomposition chemistry

5.4.10.2. Stability studies

5.4.10.3. Results and conclusions

5.5. DRUG PRODUCT

5.5.1. Description and composition of the drug product

5.5.2. Composition

5.5.3. Pharmaceutical development.

5.6. MANUFACTURE

5.6.1. Manufacturer(s)

5.6.2. Batch formula

5.6.3. Description of manufacturing process and process controls

5.7. IN-PROCESS CONTROLS

5.7.1. Controls of critical steps and intermediates

5.7.2. Process validation and/or evaluation

5.8. CONTROL OF EXCIPIENTS

5.8.1. Specifications

5.8.2. Excipients of human or animal origin

5.8.3. Novel excipients

5.9. CONTROL OF DRUG PRODUCT

5.9.1. Specification(s)

5.9.2. Analytical procedures

5.9.3. Description of [18F]NaF injection

5.9.4. pH of [18F]NaF injection by pH paper

5.9.5. Bacterial endotoxin contents in [18F]NaF injection by limulus amebocyte lysate

5.9.6. Validation of analytical procedures

5.9.7. Characterization of impurities

5.9.8. Justification of specification(s)

5.9.9. Reference standards or materials

5.9.10. Container closure system

5.9.11. Stability

6. PART II PHARMACO-TOXICOLOGICAL DATA

6.1. PHARMACOLOGY

6.1.1. Summary

6.1.2. Primary pharmacodynamics

6.1.3. Secondary pharmacodynamics

6.2. SAFETY PHARMACOLOGY

6.2.1. History of Na18F-PET imaging

6.3. PHARMACOKINETICS

6.3.1. Summary

6.4. TOXICOLOGY

6.4.1. Summary

6.4.2. Reproductive toxicology

6.4.3. Mutagenicity and genotoxicity

6.4.4. Discussion and conclusion

6.5. CLINICAL DATA

6.5.1. Introduction

6.5.2. Role of [18F]NaF injection in detection of bone metastases

6.5.3. Study objectives and endpoints

6.5.4. Trial design

6.5.5. Data analysis

I.1. RADIOPHARMACEUTICAL

I.2. RADIOCHEMICALS AND RADIOPHARMACEUTICALS

I.3 REGULATORY REFERENCES AND DEFINITIONS

I.3.1. Good manufacturing practice

I.3.2 Good clinical practice

I.3.3 Pharmacopoeia standard

I.3.4 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

I.3.5 Declaration of Helsinki

I.3.6 Regulatory agencies

I.3.7 Magistral formula

I.3.8 Officinal formula

I.3.9 Investigational medical product / investigational new drug

I.4 CLINICAL TRIALS

I.5 LICENSED AND UN-LICENSED RADIOPHARMACEUTICALS

II.1 EUROPEAN UNION

II.2 JAPAN

II.3 UNITED STATES OF AMERICA

II.4 AUSTRALIA

Type of Study

Product Name

References

ACRONYMS AND ABBREVIATIONS.

Notes:

Includes bibliographical references.

Description based on online resource; title from PDF title page (ebrary, viewed June 2, 2017).

ISBN:

92-0-116119-0

OCLC:

951621500