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Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry - PharmaFacts
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Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry

Osteoporosis:

Nonclinical Evaluation

of Drugs Intended for

Treatment Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact Samantha Bell at 301-796-9687.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2016 Pharmacology/Toxicology

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15004dft.doc 06/01/16

Osteoporosis:

Nonclinical Evaluation

of Drugs Intended for

Treatment Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2016 Pharmacology/Toxicology

 

I. II. III.

A. B.

TABLE OF CONTENTS

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 2 NONCLINICAL STUDIES.............................................................................................. 2 Toxicology Studies ......................................................................................................................... 2 Bone Quality Studies...................................................................................................................... 2

1. Animal Species and Models ............................................................................................................. 2

  1. Two-species requirement .......................................................................................................... 2

  2. Osteoporosis models ................................................................................................................. 3

  3. Studies to support other osteoporosis indications ..................................................................... 3

2. Study Design .................................................................................................................................... 3

  1. Dose selection ........................................................................................................................... 3

  2. Dosing regimen and administration route.................................................................................3

  3. Study duration ........................................................................................................................... 4

  4. Data analysis ............................................................................................................................. 4

3. Evaluations ...................................................................................................................................... 4

  1. Bone turnover ............................................................................................................................ 4

  2. Bone mass and density..............................................................................................................4

  3. Bone structure and architecture................................................................................................. 4

  4. Bone strength ............................................................................................................................ 5

  5. Additional evaluations .............................................................................................................. 5

Biopharmaceuticals ....................................................................................................................... 6

REGULATORY ASPECTS............................................................................................. 6

C. IV.

V. REFERENCES.............................................................................................................................. 8

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