M. Shapiro

发表

An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology

N. Nikolov, M. Shapiro, 2017, Nature Reviews Rheumatology.

Considerations for the development of therapeutic monoclonal antibodies.

Patrick G. Swann, B. Rellahan, P. Swann, 2008, Current opinion in immunology.

Regulatory Considerations in the Development of Monoclonal Antibodies for Diagnosis and Therapy

Patrick G. Swann, P. Swann, M. Ricci, 2014 .

U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

R. Pazdur, A. Khandelwal, F. Borrego, 2012, Clinical Cancer Research.

Antibody–Drug Conjugate Development

A. Khandelwal, Hong Zhao, H. Saber, 2013 .

FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia

Jiang Liu, R. Pazdur, C. Ko, 2018, Clinical Cancer Research.

U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia

R. Pazdur, R. Justice, C. Ko, 2014, Clinical Cancer Research.

An FDA perspective on the implementation of state-of-the-art analytical methods for therapeutic proteins

Marjorie Shapiro, M. Shapiro, 2017 .

Characterization of Therapeutic Proteins

E. B. Struble, N. Kirschbaum, J. Liu, 2016 .

Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies

D. Scott, Jonathan M O Rawson, T. Stantchev, 2023, Pharmaceutics.

Regulatory considerations for development of bioanalytical assays for biotechnology products.

Patrick G. Swann, Patrick G Swann, M. Shapiro, 2011, Bioanalysis.

U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

R. Pazdur, A. Khandelwal, F. Borrego, 2012, Clinical Cancer Research.