Volume 50; Issue 6

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Therapeutic Innovation & Regulatory Science
Volume 50; Issue 6

Therapeutic Innovation & Regulatory Science

Volume 50; Issue 6

1

Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development

McMahon, A. W., Watt, K., Wang, J., Green, D., Tiwari, R., Burckart, G. J.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 264 KB

english, 2016

2

An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency

Do rr, P., Wadworth, A., Wang, T., McAuslane, N., Liberti, L.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 400 KB

english, 2016

3

Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013

Yang, X., Thompson, L., Chu, J., Liu, S., Lu, H., Zhou, J., Gomatam, S., Tang, R., Zhao, Y., Ge, Y., Gray, G. W.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 181 KB

english, 2016

4

Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications: Lessons Learned

Wang, J., Wolka, A., Bullok, K., Anglin, G., Radawski, C., Noel, R.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 225 KB

english, 2016

5

Glory Enough for All

Spielberg, S. P.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 54 KB

english, 2016

6

Can Registration Procedures of Pharmaceuticals Inadvertently Contribute to Off-Label Prescribing in Children?

Ellul, I., Grech, V., Attard-Montalto, S.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 170 KB

english, 2016

7

Evaluating the Effectiveness of Repricing for Market Expansion in the Japanese Drug Pricing System

Shibata, S., Uemura, R., Suzuki, T.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 414 KB

english, 2016

8

Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

Jarow, J. P., Lemery, S., Bugin, K., Khozin, S., Moscicki, R.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 253 KB

english, 2016

9

Pharmaceutical Organizational Size and Phase 3 Clinical Trial Completion Times

Glass, H. E., Glass, L. M., Tran, P., Alghamdi, H.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 138 KB

english, 2016

10

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Schnell, P. M., Ball, G.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 267 KB

english, 2016

11

Novel Gastroretentive Controlled Release Formulations for Once-Daily Administration: Assessment of Clinical Feasibility and Formulation Concept for Raltegravir

Krishna, R., Rizk, M. L., Larson, P. J., Schulz, V., Friedman, E., Gupta, P., Kesisoglou, F., Connor, A., McDermott, J., Smith, R., Evans, P.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 348 KB

english, 2016

12

The PharmD/MD Dual-Degree Program and Its Potential Value in the Pharmaceutical Industry

Shah, Khushbu S., Marwah, Upasana, Bundra, Kristina, Goldin, Carol S., Toscani, Michael, Barone, Joseph A., Colaizzi, John L.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 349 KB

english, 2016

13

Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials

Sakamaki, Kentaro, Kamiura, Toshifumi, Morita, Yusuke, Iba, Katsuhiro, Yoshida, Seitaro, Wakana, Akira, Tsuchiya, Satoru, Fukimbara, Satoru, Suganami, Hideki

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 213 KB

english, 2016

14

Postmarketing Benefit-Risk Assessment for Erythropoiesis-Stimulating Agents Using a Health Care Database

Sugitani, Yasuo, Udagawa, Yukio, Matsuda, Shinichi, Yamada, Kana, Miyawaki, Natsuko, Konishi, Ichiro

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 1.29 MB

english, 2016

15

Optimizing the Use of Electronic Data Sources in Clinical Trials

Kellar, Ed, Bornstein, Susan M., Caban, Aleny, Célingant, Catherine, Crouthamel, Michelle, Johnson, Chrissy, McIntire, Patricia A., Milstead, Kenneth R., Patterson, Jaclyn K., Wilson, Brett

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 1.01 MB

english, 2016

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