Application of Clinical Pharmacology Principles in Drug Development of Modified‐Release Products: Leveraging Exposure‐Response Information to Support Approval

Author:

AbuAsal Bilal S.1,Hamed Salaheldin S.1,Ahmed Mariam A.1,Al‐Mansour Lana1,Uppoor Ramana1,Mehta Mehul1

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference20 articles.

1. Sustained-Release, Extended-Release, and Other Time-Release Formulations in Neuropsychiatry

2. Specific pharmacology of long‐acting, extended‐release, and sustained‐release opioids for the treatment of chronic nonmalignant pain;Sloan PA;J Opioid Manag,2015

3. FDA. FDA Guidance: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations.https://wwwfdagov/media/121311/download. Accessed April 29 2020.

4. FDA. FDA Guidance: Exposure‐Response Relationships—Study Design Data Analysis and Regulatory Applications.https://wwwfdagov/media/71277/download. Accessed August 24 2018.

5. FDA. FDA Guidance: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.1998.https://www.fda.gov/media/71655/download. Accessed August 24 2018.

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