European Regulatory Developments for Orally Inhaled and Nasal Drug Products von Santos, Carlos, Marco, Gustavo, Nagao, Lee M., Castro, Eva, Chesworth, Tim

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Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – Current challenges and approaches von Broschard, Thomas H., Glowienke, Susanne, Bruen, Uma S., Nagao, Lee M., Teasdale, Andrew, Stults, Cheryl L.M., Li, Kim L., Iciek, Laurie A., Erexson, Greg, Martin, Elizabeth A., Ball, Douglas J.

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Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies von Parris, Patricia, Martin, Elizabeth A., Stanard, Brad, Glowienke, Susanne, Dolan, David G., Li, Kim, Binazon, Ornella, Giddings, Amanda, Whelan, Geraldine, Masuda-Herrera, Melisa, Bercu, Joel, Broschard, Thomas, Bruen, Uma, Callis, Courtney M., Stults, Cheryl L.M., Erexson, Gregory L., Cruz, Maureen T., Nagao, Lee M.

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Collaborations between Clinical Pharmacologists in Japan and in the United States ‐ Report from the IQ CPLG and JPMA CPTF Meeting in Tokyo, Japan von Zhu, Tong, Kayama, Makoto, Girish, Sandhya, Sinha, Vikram, Bello, Akintunde, Kawaguchi, Atsuhiro, Czerniak, Richard, Nagao, Lee

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Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study von Teasdale, Andrew, Jahn, Michael, Bailey, Simon, Feilden, Andrew, Taylor, Graham, Corcoran, Marta L., Malick, Robert, Jenke, Dennis, Stults, Cheryl L. M., Nagao, Lee M.

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Risk Management for Materials and Components Used in Orally Inhaled and Nasal Drug Products von Stults, Cheryl L. M., Reckzuegel, Gaby, Bailey, Arthur, Petersen, Jonathan, Dick, Lisa, Feinberg, Thomas, Feilden, Andrew, Miller, Sara, Connors, James, Nagao, Lee M.

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Evaluation of Extractables in Processed and Unprocessed Polymer Materials Used for Pharmaceutical Applications von Stults, Cheryl L. M., Ansell, Jennifer M., Shaw, Arthur J., Nagao, Lee M.

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Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations von Norwood, Daniel L., Paskiet, Diane, Ruberto, Michael, Feinberg, Thomas, Schroeder, Alan, Poochikian, Guirag, Wang, Qingxi, Deng, Tian Jing, DeGrazio, Fran, Munos, Melinda K., Nagao, Lee M.

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A Risk-Based Approach to Management of Leachables Utilizing Statistical Analysis of Extractables von Stults, Cheryl L. M., Mikl, Jaromir, Whelehan, Oliver, Morrical, Bradley, Duffield, William, Nagao, Lee M.

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Cell and Gene Therapies: Challenges in Designing Extractables and Leachables Studies and Conducting Safety Assessments von Arroyo, Adeyma, Booij, Petra, Woldemariam, Getachew, Bruen, Uma, Creasey, Jason, Stanard, Brad, Parris, Patricia, Nagao, Lee, Bielinski, Mary Kate

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Introduction to the IQ Consortium and the IQ Clinical Pharmacology Leadership Group von Li, Chunze, Magee, Mindy, Younis, Islam, Nagao, Lee

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Aspects of Particle Science and Regulation in Pharmaceutical Inhalation Drug Products von Nagao, Lee M, Lyapustina, Svetlana, Munos, Melinda K, Capizzi, Mary Devlin

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An Overview and Discussion of N-nitrosamine Considerations for Orally Inhaled Drug Products and Relevance to Other Dosage Forms von Khan, Hera Shams, Despres-Gnis, Fabienne, Stults, Cheryl L. M., Mullis, James, Nugara, Niran, Sen, Atish, Nagao, Lee

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Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program von Galluppi, Gerald R., Brar, Satjit, Caro, Luzelena, Chen, Yuan, Frey, Nicolas, Grimm, Hans Peter, Rudd, Deanne Jackson, Li, Chi‐Chung, Magee, Mindy, Mukherjee, Arnab, Nagao, Lee, Purohit, Vivek S., Roy, Amit, Salem, Ahmed Hamed, Sinha, Vikram, Suleiman, Ahmed A., Taskar, Kunal S., Upreti, Vijay V., Weber, Benjamin, Cook, Jack

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Spray Pattern and Plume Geometry Testing and Methodology: An IPAC-RS Working Group Overview von Baxter, Sherryl, Myatt, Ben, Stein, Stephen, Parkinson, Adrian, Chambers, Frank, Doub, Bill, Grmas, Jernej, Suman, Julie, Miller, Keith, Sinha, Biswadip, Liao, Linda, Carter, Ian, Farina, Dino, Sarrailh, Segolene, Fischer, Manfred, Walsh, Declan, Nagao, Lee

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Foreign particles testing in orally inhaled and nasal drug products von Blanchard, James, Coleman, James, Hayling, Claire D'Abreu, Ghaderi, Raouf, Haeberlin, Barbara, Hart, John, Jensen, Steen, Malcolmson, Richard, Mittelman, Stanley, Nagao, Lee M, Sekulic, Sonja, Snodgrass-Pilla, Caesar, Sundahl, Mikael, Thompson, Glenn, Wolff, Ronald

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Impact of COVID19 on Clinical Trials Design and Conduct von Mohamed, Mohamed-Eslam, Zhu, Tong, Girish, Sandhya, Burkhard, Ute, Cheeti, Sravanthi, Datta-Mannan, Amita, Desai, Amit, Gheyas, Ferdous, Humeniuk, Rita, Kanodia, Jitendra, Kavetska, Olga, Nagao, Lee, Rizwan, Ahsan, Tammara, Brinda, Wang, Erjian, Xu, Christine

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Introduction of IQ CPLG：Missions and Activities von 吉次, 広如, 武藤, 智恵子, Li, Chunze, Zhu, Tong, Vikram, Sinha, Lee, Nagao

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Introduction of and Updates from the IQ Consortium Clinical Pharmacology Leadership Group von Nagao, Lee M.

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Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products von Silva, Marcia Cavallin, Costa, Helena Silveira, Valadares, Bruna Nardy, Grecchi, Leticia, Nagao, Lee, Santos, Gustavo Mendes Lima

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