New FDA Draft Guidance on Immunogenicity

Por Parenky, Ashwin, Myler, Heather, Amaravadi, Lakshmi, Bechtold-Peters, Karoline, Rosenberg, Amy, Kirshner, Susan, Quarmby, Valerie
Publicado em 2014

The pharmacokinetics of peginterferon lambda-1a following single dose administration to subjects with impaired renal function

Por Hruska, Matthew W, Adamczyk, Robert, Colston, Elizabeth, Hesney, Michael, Stonier, Michele, Myler, Heather, Bertz, Richard
Publicado no Br J Clin Pharmacol (2015)

Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Por Stevenson, Lauren, Kelley, Marian, Gorovits, Boris, Kingsley, Clare, Myler, Heather, Österlund, Karolina, Muruganandam, Arumugam, Minamide, Yoshiyuki, Dominguez, Mario
Publicado em 2013

Pre-existing Antibody: Biotherapeutic Modality-Based Review

Por Gorovits, Boris, Clements-Egan, Adrienne, Birchler, Mary, Liang, Meina, Myler, Heather, Peng, Kun, Purushothama, Shobha, Rajadhyaksha, Manoj, Salazar-Fontana, Laura, Sung, Crystal, Xue, Li
Publicado no AAPS J (2016)

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development...

Por Lee, Jean W., Kelley, Marian, King, Lindsay E., Yang, Jihong, Salimi-Moosavi, Hossein, Tang, Meina T., Lu, Jian-Feng, Kamerud, John, Ahene, Ago, Myler, Heather, Rogers, Cindy
Publicado em 2011

FGF21 Analogs of Sustained Action Enabled by Orthogonal Biosynthesis Demonstrate Enhanced Antidiabetic Pharmacology in Rodents

Por Mu, James, Pinkstaff, Jason, Li, Zhihua, Skidmore, Lillian, Li, Nina, Myler, Heather, Dallas-Yang, Qing, Putnam, Anna-Maria, Yao, Jun, Bussell, Stuart, Wu, Margaret, Norman, Thea C., Rodriguez, Carlos G., Kimmel, Bruce, Metzger, Joseph M., Manibusan, Anthony, Lee, Darin, Zaller, Dennis M., Zhang, Bei B., DiMarchi, Richard D., Berger, Joel P., Axelrod, Douglas W.
Publicado em 2012

A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Por Foster, Graham R., Chayama, Kazuaki, Chuang, Wan-Long, Fainboim, Hugo, Farkkila, Martti, Gadano, Adrian, Gaeta, Giovanni B., Hézode, Christophe, Inada, Yukiko, Heo, Jeong, Kumada, Hiromitsu, Lu, Sheng-Nan, Marcellin, Patrick, Moreno, Christophe, Roberts, Stuart K., Strasser, Simone I., Thompson, Alexander J., Toyota, Joji, Paik, Seung Woon, Vierling, John M., Zignego, Anna L., Cohen, David, McPhee, Fiona, Wind-Rotolo, Megan, Srinivasan, Subasree, Hruska, Matthew, Myler, Heather, Portsmouth, Simon D.
Publicado no Springerplus (2016)