Articles, White Papers, & Publications

The absence of genotoxicity of a mixture of aloin A and B and a commercial aloe gel beverage A.Wallace Hayes, Roger A. Clemens and Peter Pressman (Toxicology Mechanisms and Methods, December 2021)

https://uscregsci.box.com/s/dz1hpsupyeq1y635dgowf26l4hw5sjjk

Phytonutrient Inhibitors of SARS-CoV-2/NSP5-Encoded Main Protease (Mpro) Autocleavage Enzyme Critical forCOVID-19 Pathogenesis Sreus A. G. Naidu , Yamini B. Tripathi, Priya Shree, Roger A. Clemens and A. Satyanarayan Naidu (Journal of Dietary Supplements, November 2021)

https://uscregsci.box.com/s/f71fbzpmbwmufh0dukw6uxu4gijujg1a

A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China Neal E. Storm DRSc, MS, MBA, RAC, Wen Chang PhD, Tzu-Chieh Lin PhD, Jeff L. Lange PhD, Brian Bradbury DSc, Cathy W. Critchlow PhD & Steven K. Galson MD, MPH – https://link.springer.com/article/10.1007/s43441-021-00342-4 (Therapeutic Innovation & Regulatory Science, October 2021)

Turning Neural Prosthetics Into Viable Products Gerald E. Loeb1 and Frances J. Richmond2; 1Medical Device Development Facility, Department of Biomedical Engineering, University of Southern California, Los Angeles, CA, United States; 2DK Kim International Center for Regulatory Science, Department of Regulatory and Quality Sciences, University of Southern California, Los Angeles, CA, United States (pdf) (Policy and Practice Reviews, September 2021)

https://uscregsci.box.com/s/6yoehouuxiongyyfeb9ob3v2aicfijj3

Streamlining processes – the WHO Collaborative Procedure for Accelerated Registration in Africa Lori Alquier, Department of Regulatory & Quality Sciences, University of Southern California School of Pharmacy, US, Frances J. Richmond, Director, DK Kim International Center for Regulatory Science, Professor, Department of Regulatory & Quality Sciences, University of Southern California School of Pharmacy, US (pdf) (Regulatory Rapporteur, September 2021) https://uscregsci.box.com/s/eswu7sxbd9xuu9qasu448rymowue59nx

Promising new agents may require expansion of guidelines for subject screening in clinical trials Peter Pressman, Roger Clemens, Thomas Blackburn, and A. Wallace Hayes (Toxicology Research and Application, Jun 2021) (pdf)

https://uscregsci.box.com/s/tdg5e6mui8fzvbwmnm9ur9l0757m93ik

Pathobiology of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) at Maternal-Fetal Interface Sreus A. G. Naidu, MS, PharmD, Roger A. Clemens, DrPH, FIFT, CFS, FASN, FACN, CNS, FIAFST, Peter Pressman, MD, MS, FACN, Mehreen Zaigham, BSc, MD, PhD, Kamran Kadkhoda, PhD, SM(ASCP), D(ABMM), D(ABMLI), Kelvin J. A. Davies, PhD, DSc, MAE, FRSC, FRCP, FLS, FRI & A. Satyanarayan Naidu, PhD, FACN, FLS, FISSVD (Journal of Dietary Supplements, Nov. 2020) (pdf) https://uscregsci.box.com/s/5u0ta2hulh8sv7wgjel2tsr9jrw7drln

COVID-19 during Pregnancy and Postpartum: Antiviral Spectrum of Maternal Lactoferrin in Fetal and Neonatal Defense Sreus A. G. Naidu, MS, PharmD, Roger A. Clemens, DrPH, FIFT, CFS, FASN, FACN, CNS, FIAFST, Peter Pressman, MD, MS, FACN, Mehreen Zaigham , BSc, MD, PhD, Kelvin J. A. Davies , PhD, DSc, MAE, FRSC, FRCP, FLS, FRI & A. Satyanarayan Naidu, PhD, FACN, FLS, FISSVD (Journal of Dietary Supplements, Nov. 2020) (pdf) https://uscregsci.box.com/s/a1ch2q3l4nsj20s75eqfvsu1dze1tcqd

Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018) by Seo, Y., & Pacifici, E. (Vaccine, November 2020).  https://www.sciencedirect.com/science/article/pii/S0264410X20312494?via%3Dihub

Emerging Digital Health Solutions_ Inherent Challenges in the Technology Driven World, by Darin S. Oppenheimer, (DRSc ’17), George A. Cusatis, Suraj Ramachandran, Jessica L. Hale (RAPS, November 2019) (pdf) https://uscregsci.box.com/s/3cfgwcigl60tdn8rcwwb4w0z2kev73pk

Medical Device Cybersecurity Regulatory Pathway, by Carolyn Wright, MS, DRSc candidate (RAPS, July 2019) (pdf) https://uscregsci.box.com/s/jxfpsrid635aqcn1yt0x9tzjd8a6u7aq

Novel Fixed Dose Combination Therapies, by Monique Carter (DRSc candidate) & Saima Khan (Nature, April 2019) https://www.nature.com/articles/d41573-019-00066-z

 

Postmarket Surveillance in a Digital Health Solution World, by Darin Oppenheimer DRSc (’17), Guo, Hale, Cusatis, Ramachandran, & Visc0 (RAPS, January 2019) (pdf) https://uscregsci.box.com/s/ae2csoqgmwnhoemt9twcy4gfcwvr0w8l

 

Medical Device and Risk Management, by Darin Oppenheimer DRSc (’17) and Suraj Ramachandran (RAPS, February 2018) (pdf)

Connected Device System Validation & Quality – Best Practices; by Carolyn Wright, USC Reg Sci DRSc student (IVT Journal, August 2017)

Standard Comparison: Assessing risk management processes for regulated health industries; by Carolyn Wright, USC RegSci DRSc student (Quality Progress, June 2017) (pdf)

Role of Purinergic P2X4 Receptors in Regulating Striatal Dopamine Homeostasis and Dependent Behaviors. Journal of Neurochemistry; Khoja S, Shah V, Garcia D, Asatryan L, Jakowec MW, Davies DL. Accepted for publication; in press.

A Pilot Study of the Safety and Initial Efficacy of Ivermectin for the Treatment of Alcohol Use Disorder; Daryl Davies, Ph.D. et all (April 2016)

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals; Daryl Davies, Ph.D. et all (March 2016)

ICH Revisions for Benefit-risk Assessment by Nancy Smerkanich, DRSc (January 2016) (pdf)

3rd Annual Proceedings of the BMES ERC/IBT Summer Research Programs (Summer 2015) (pdf)

Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings; Cesar Medina, DRSc and Frances Richmond, PhD (May 2015). (pdf)

Cultivating Talent for Korea’s Biopharmaceutical Industry; Eunjoo Pacifici, PharmD, PhD 
English (pdf) –Korean (pdf)

Options in Regulatory Affairs- Specialties and Skill Sets; Nancy Pire-Smerkanich and David Locke (March 2015) (pdf) 

Escalation of Oncologic Services at the End of Life Among Patients with Gynecologic Cancer at an Urban Public Hospital; Terry Church, et al (February 2015). (pdf)

 
Medical Device and Risk Management, by Darin Oppenheimer DRSc (’17) and Suraj Ramachandran (RAPS, February 2018) (pdf)

Connected Device System Validation & Quality – Best Practices; by Carolyn Wright, USC Reg Sci DRSc student (IVT Journal, August 2017)

Standard Comparison: Assessing risk management processes for regulated health industries; by Carolyn Wright, USC RegSci DRSc student (Quality Progress, June 2017) (pdf)

Role of Purinergic P2X4 Receptors in Regulating Striatal Dopamine Homeostasis and Dependent Behaviors. Journal of Neurochemistry; Khoja S, Shah V, Garcia D, Asatryan L, Jakowec MW, Davies DL. Accepted for publication; in press.

A Pilot Study of the Safety and Initial Efficacy of Ivermectin for the Treatment of Alcohol Use Disorder; Daryl Davies, Ph.D. et all (April 2016)

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals; Daryl Davies, Ph.D. et all (March 2016)

ICH Revisions for Benefit-risk Assessment by Nancy Smerkanich, DRSc (January 2016) (pdf)

3rd Annual Proceedings of the BMES ERC/IBT Summer Research Programs (Summer 2015) (pdf)

Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings; Cesar Medina, DRSc and Frances Richmond, PhD (May 2015). (pdf)

Cultivating Talent for Korea’s Biopharmaceutical Industry; Eunjoo Pacifici, PharmD, PhD 
English (pdf) –Korean (pdf)

Options in Regulatory Affairs- Specialties and Skill Sets; Nancy Pire-Smerkanich and David Locke (March 2015) (pdf) 

Escalation of Oncologic Services at the End of Life Among Patients with Gynecologic Cancer at an Urban Public Hospital; Terry Church, et al (February 2015). (pdf)