Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model

In this topical collection (20 articles)

1. 

   Research Article

   Decision Support for Excipient Risk Assessment in Pharmaceutical Manufacturing

   Andres Bejarano, Chandima Hewa Nadungodage, Fang Wang… Article:223

2. 

   Review Article

   Predictive and Accelerated Formulation Design Using Synchrotron Methods

   Stephen R. Byrn, Xiaoming Sean Chen, Pamela A. Smith Article:176

3. 

   Research Article

   Development and Validation of Sample Preparation and an HPLC Analytical Method for Dissolution Testing in Fed-State Simulated Gastric Fluid—Illustrating Its Application for Ibuprofen and Ketoconazole Immediate Release Tablets

   Harsh S. Shah, Rusha Sardhara, Kajal Nahar, Ting Xu, Poonam Delvadia… Article:172

4. 

   Review Article

   Lesson Learnt from Recall of Valsartan and Other Angiotensin II Receptor Blocker Drugs Containing NDMA and NDEA Impurities

   Naseem Ahmad Charoo, Areeg Anwer Ali, Shailesh Kumar Buha… Article:166

5. 

   Research Article

   Feedforward and Feedback Control of a Pharmaceutical Coating Process

   Yuxiang Zhao, James K. Drennen, Shikhar Mohan, Suyang Wu… Article:157

6. White Paper

   In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs

   Vadim J. Gurvich, Ajaz S. Hussain Article:153

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7. White Paper

   Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence

   Ajaz S. Hussain, Vadim J. Gurvich, Kenneth Morris Article:140

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8. 

   Research Article

   Determination of Rate and Extent of Scopolamine Release from Transderm Scōp® Transdermal Drug Delivery Systems in Healthy Human Adults

   Suresh Kumar Swaminathan, Caroline Strasinger, Megan Kelchen… Article:117

9. Editorial

   Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue

   Ajaz S. Hussain, Kenneth Morris, Vadim J. Gurvich Article:88

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10. 

    Review Article

    Pediatric Formulations: Knowledge Gaps Limiting the Expedited Preclinical to Clinical Translation in Children

    Monika Lavan, Stephen R. Byrn, Gregory Knipp Article:73

11. 

    Research Article

    New Insights on Solid-State Changes in the Levothyroxine Sodium Pentahydrate during Dehydration and its Relationship to Chemical Instability

    Harsh S. Shah, Kaushalendra Chaturvedi, Mazen Hamad, Simon Bates… Article:39

12. 

    Research Article

    Influence of Formulation Factors on the Aerosol Performance and Stability of Lysozyme Powders: a Systematic Approach

    Silvia Ferrati, Tian Wu, Omar Fuentes, Ashlee D. Brunaugh… Pages 2755-2766

13. 

    Research Article

    A Simplified Geometric Model to Predict Nasal Spray Deposition in Children and Adults

    Mow Yee Foo, Namita Sawant, Ellen Overholtzer, Maureen D. Donovan Pages 2767-2777

14. 

    Research Article

    The Sensitivity of In Vitro Permeation Tests to Chemical Penetration Enhancer Concentration Changes in Fentanyl Transdermal Delivery Systems

    Soo Hyeon Shin, Jukkarin Srivilai, Sarah A. Ibrahim… Pages 2778-2786

15. 

    Research Article

    Particle Size Distribution Equivalency as Novel Predictors for Bioequivalence

    Pratak Ngeacharernkul, Stephen D. Stamatis, Lee E. Kirsch Pages 2787-2800

16. 

    Research Article

    Using Manufacturing Design Space Concepts for Stability Risk Assessment—Gabapentin NIPTE/FDA Case Study

    Stephen D. Stamatis, Lee E. Kirsch Pages 2801-2807

17. Editorial

    The Impact of the National Institute for Pharmaceutical Technology and Education on Academic Research

    Marilyn K. Speedie Pages 2808-2811

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18. 

    Research Article

    Sensitive Determination of Fentanyl in Low-Volume Serum Samples by LC-MS/MS

    Suresh Kumar Swaminathan, James Fisher, Karunya K. Kandimalla Pages 2812-2817

19. 

    Research Article

    Scale-Up and In-line Monitoring During Continuous Melt Extrusion of an Amorphous Solid Dispersion

    Abbe Haser, Brian Haight, Andreas Berghaus, Augie Machado… Pages 2818-2827

20. 

    Research Article

    Impact of Natural Variations in Freeze-Drying Parameters on Product Temperature History: Application of Quasi Steady-State Heat and Mass Transfer and Simple Statistics

    Michael J. Pikal, Paritosh Pande, Robin Bogner, Pooja Sane… Pages 2828-2842