Search Results - "Liao, Michael Z."

Clinical Pharmacology Considerations on Recombinant Adeno‐Associated Virus–Based Gene Therapy by Sun, Kefeng, Liao, Michael Z.

“…Recombinant adeno‐associated virus (AAV) is currently the most widely used platform for in vivo gene therapy. Clinical pharmacology is a central field for AAV…”
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Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates? by Liao, Michael Z., Lu, Dan, Kågedal, Matts, Miles, Dale, Samineni, Divya, Liu, Stephanie N., Li, Chunze

“…Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the cytotoxicity of a chemical agent. They represent a rapidly evolving area of…”
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The PSMA-targeting Half-life Extended BiTE Therapy AMG 160 has Potent Antitumor Activity in Preclinical Models of Metastatic Castration-resistant Prostate Cancer by Deegen, Petra, Thomas, Oliver, Nolan-Stevaux, Olivier, Li, Shyun, Wahl, Joachim, Bogner, Pamela, Aeffner, Famke, Friedrich, Matthias, Liao, Michael Z, Matthes, Katja, Rau, Doris, Rattel, Benno, Raum, Tobias, Kufer, Peter, Coxon, Angela, Bailis, Julie M

“…Metastatic castration-resistant prostate cancer (mCRPC) remains a disease with high unmet medical need, as most patients do not achieve durable response with…”
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Patient, industry, and regulatory perspective on antibody‐drug conjugates dose optimization by Hamed, Salaheldin, Li, Chunze, Liao, Michael Z., Warwick, Lorna, Zhou, Zhu

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Pharmacokinetics of biologics in gastric cancer by Li, Junyi, Turner, David C., Li, Feifei, Chen, Xi, Liao, Michael Z., Li, Chunze

“…Gastric cancer (GC) remains one of the leading causes of cancer death worldwide despite improvements in therapeutic options. Several biologics have been…”
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P-gp/ABCB1 exerts differential impacts on brain and fetal exposure to norbuprenorphine by Liao, Michael Z., Gao, Chunying, Shireman, Laura M., Phillips, Brian, Risler, Linda J., Neradugomma, Naveen K., Choudhari, Prachi, Prasad, Bhagwat, Shen, Danny D., Mao, Qingcheng

“…[Display omitted] Norbuprenorphine is the major active metabolite of buprenorphine which is commonly used to treat opiate addiction during pregnancy…”
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Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non‐Asian patients with previously untreated diffuse large B‐cell lymphoma in POLARIX by Liao, Michael Z., Deng, Rong, Gibiansky, Leonid, Lu, Tong, Agarwal, Priya, Dere, Randall, Lee, Calvin, Hirata, Jamie, Herbaux, Charles, Salles, Gilles, Li, Chunze, Miles, Dale

“…This ethnic sensitivity analysis used data from the phase III POLARIX study (NCT03274492) to assess polatuzumab vedotin pharmacokinetics (PKs) in Asian versus…”
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Population pharmacokinetics and exposure–response analyses of polatuzumab vedotin in patients with previously untreated DLBCL from the POLARIX study by Deng, Rong, Gibiansky, Leonid, Lu, Tong, Flowers, Christopher R., Sehn, Laurie H., Liu, Qi, Agarwal, Priya, Liao, Michael Z., Dere, Randall, Lee, Calvin, Man, Gabriel, Hirata, Jamie, Li, Chunze, Miles, Dale

“…Polatuzumab vedotin is a CD79b‐directed antibody–drug conjugate that targets B cells and delivers the cytotoxic payload monomethyl auristatin E (MMAE). The…”
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Quantitative Proteomics Reveals Changes in Transporter Protein Abundance in Liver, Kidney and Brain of Mice by Pregnancy by Liao, Michael Z, Gao, Chunying, Bhatt, Deepak Kumar, Prasad, Bhagwat, Mao, Qingcheng

“…Few studies have systematically investigated pregnancy-induced changes in protein abundance of drug transporters in organs important for drug/xenobiotic…”
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Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study by Al-Sawaf, Othman, Zhang, Can, Lu, Tong, Liao, Michael Z, Panchal, Anesh, Robrecht, Sandra, Ching, Travers, Tandon, Maneesh, Fink, Anna-Maria, Tausch, Eugen, Schneider, Christof, Ritgen, Matthias, Böttcher, Sebastian, Kreuzer, Karl-Anton, Chyla, Brenda, Miles, Dale, Wendtner, Clemens-Martin, Eichhorst, Barbara, Stilgenbauer, Stephan, Jiang, Yanwen, Hallek, Michael, Fischer, Kirsten

“…The CLL14 study has established one-year fixed-duration treatment of venetoclax and obinutuzumab (Ven-Obi) for patients with previously untreated chronic…”
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Buprenorphine, Norbuprenorphine, R-Methadone, and S-Methadone Upregulate BCRP/ABCG2 Expression by Activating Aryl Hydrocarbon Receptor in Human Placental Trophoblasts by Neradugomma, Naveen K, Liao, Michael Z, Mao, Qingcheng

“…Opioid dependence during pregnancy is a rising concern. Maintaining addicted pregnant women on long-acting opioid receptor agonist is the most common strategy…”
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Clinical Pharmacology Perspectives for Adoptive Cell Therapies in Oncology by Huang, Weize, Li, Junyi, Liao, Michael Z., Liu, Stephanie N., Yu, Jiajie, Jing, Jing, Kotani, Naoki, Kamen, Lynn, Guelman, Sebastian, Miles, Dale R.

“…Adoptive cell therapies (ACTs) have shown transformative efficacy in oncology with five US Food and Drug Administration (FDA) approvals for chimeric antigen…”
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Translational PK/PD framework for antibody-drug conjugates to inform drug discovery and development by Liao, Michael Z, Leipold, Douglas D, Chen, Shang-Chiung, Li, Zao, Kamath, Amrita V, Li, Chunze

“…(171/200)ADCs represent a transformative class of medicine that combines the specificity of monoclonal antibodies with the potency of highly cytotoxic agents…”
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Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings by Liao, Michael Z., Lu, Dan, Lu, Tong, Gibiansky, Leonid, Deng, Rong, Samineni, Divya, Dere, Randall, Lin, Andy, Hirata, Jamie, Shen, Ben-Quan, Zhang, Donglu, Li, Dongwei, Li, Chunze, Miles, Dale

“…[Display omitted] The favorable benefit–risk profile of polatuzumab vedotin, as demonstrated in a pivotal Phase Ib/II randomized study (GO29365; NCT02257567),…”
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The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer by Liao, Michael Z., Prenen, Hans, Dutta, Sandeep, Upreti, Vijay V.

“…Purpose Panitumumab is a human monoclonal antibody targeting the epidermal growth factor receptor for the treatment of wild-type RAS metastatic colorectal…”
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Hepatic Transport of 25-Hydroxyvitamin D 3 Conjugates: A Mechanism of 25-Hydroxyvitamin D 3 Delivery to the Intestinal Tract by Gao, Chunying, Liao, Michael Z, Han, Lyrialle W, Thummel, Kenneth E, Mao, Qingcheng

“…Vitamin D is an important prohormone critical for maintaining calcium and phosphate homeostasis in the body and regulating drug-metabolizing enzymes and…”
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Hepatic Transport of 25-Hydroxyvitamin D3 Conjugates: A Mechanism of 25-Hydroxyvitamin D3 Delivery to the Intestinal Tract by Gao, Chunying, Liao, Michael Z, Han, Lyrialle W, Thummel, Kenneth E, Mao, Qingcheng

“…Vitamin D3 is an important prohormone critical for maintaining calcium and phosphate homeostasis in the body and regulating drug-metabolizing enzymes and…”
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Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR‐T and TCR‐T Cell Therapies: An Industry Perspective by Mody, Hardik, Ogasawara, Ken, Zhu, Xu, Miles, Dale, Shastri, Prathap Nagaraja, Gokemeijer, Jochem, Liao, Michael Z., Kasichayanula, Sreeneeranj, Yang, Tong‐Yuan, Chemuturi, Nagendra, Gupta, Swati, Jawa, Vibha, Upreti, Vijay V.

“…With the promise of a potentially “single dose curative” paradigm, CAR‐T cell therapies have brought a paradigm shift in the treatment and management of…”
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Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper by Sawant‐Basak, Aarti, Urva, Shweta, Mukker, Jatinder Kaur, Haertter, Sebastian, Mariano, Dean, Parasrampuria, Dolly A., Goteti, Kosalaram, Singh, Ravi Shankar Prasad, Chiney, Manoj, Liao, Michael Z., Chang, Sandy S., Mehta, Rashmi

“…The 2022 United States Food and Drug Administration (US FDA) draft guidance on diversity plan (DP), which will be implemented through the Diversity Action…”
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Effects of Pregnancy on the Pharmacokinetics of Metformin by Liao, Michael Z, Flood Nichols, Shannon K, Ahmed, Mahmoud, Clark, Shannon, Hankins, Gary D, Caritis, Steve, Venkataramanan, Raman, Haas, David, Quinney, Sara K, Haneline, Laura S, Tita, Alan T, Manuck, Tracy, Wang, Joanne, Thummel, Kenneth E, Brown, Linda Morris, Ren, Zhaoxia, Easterling, Thomas R, Hebert, Mary F

“…This study's primary objective was to fully characterize the pharmacokinetics of metformin in pregnant women with gestational diabetes mellitus (GDM) versus…”
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