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Select article: Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

Retricted access

Research article

First published 2019-1

Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

Reza Masaeli, Kavosh Zandsalimi, Lobat Tayebi

Therapeutic Innovation & Regulatory Science

Select article: A Review and Analysis of Key Regulations and Guidelines concerning the Safety Sections of the Investigator's Brochure

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Other

First published 2001-4

A Review and Analysis of Key Regulations and Guidelines concerning the Safety Sections of the Investigator's Brochure

Stephen L. Klincewicz, John A. Clark, Norman D. LaFrance

Therapeutic Innovation & Regulatory Science

Select article: The Regulation of Biological Products and the CBER-CDER Intercenter Agreements

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Research article

First published 1993-7

The Regulation of Biological Products and the CBER-CDER Intercenter Agreements

Michael E. Margolies

Therapeutic Innovation & Regulatory Science

Select article: Criteria for Approval of Controlled-Release Products

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Research article

First published 1987-4

Criteria for Approval of Controlled-Release Products

Paula Botstein

Therapeutic Innovation & Regulatory Science

Select article: The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

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Research article

First published 1995-10

The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

Kathryn Huntley, Mary Jo Veverka, Minna Golden

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Aspects of Invasive Glucose Measurements

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Research article

First published 2002-12

Regulatory Aspects of Invasive Glucose Measurements

Steve Gutman, Patricia Bernhardt, Arleen Pinkos [...]

Diabetes Technology & Therapeutics

Select article: Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy

Free access

Review article

First published 2015-6-30

Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy

Guido Freckmann, Christina Schmid, Annette Baumstark [...]

Journal of Diabetes Science and Technology

Select article: Statistical Evaluation of Drug Safety Data

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Research article

First published 2014-1

Statistical Evaluation of Drug Safety Data

H. Amy Xia, Qi Jiang

Therapeutic Innovation & Regulatory Science

Select article: Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials

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Research article

First published 2015-11

Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials

Haijun Ma, Chunlei Ke, Qi Jiang [...]

Therapeutic Innovation & Regulatory Science

Select article: On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

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Research article

First published 2020-6

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Rui Duan, Xinyuan Zhang, Jingcheng Du [...]

Health Informatics Journal

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