Risk-benefit evaluation in approval of traditional and innovative drugs
Rashmi R. Shah
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Measuring AMP‐activated protein kinase (AMPK) activity in vitro is crucial for testing AMPK activators or inhibitors with therapeutic potential. Here, we report an enzyme‐linked immunosorbent assay (ELISA)‐based AMPK activity assay with simple steps and high sensitivity, which offers a simple, robust, and cost‐effective alternative to traditional ...
Trezze P. Nguyen, Shangze Lyu, Yang Liu
wiley +1 more source
Critical insights into the evolving drug-approval process in China. [PDF]
Nikanjam M, Kurzrock R.
europepmc +1 more source
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels. [PDF]
Schultz-Knudsen K+4 more
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The tumor microenvironment is a dynamic, multifaceted complex system of interdependent cellular, biochemical, and biophysical components. Three‐dimensional in vitro models of the tumor microenvironment enable a better understanding of these interactions and their impact on cancer progression and therapeutic resistance.
Salma T. Rafik+3 more
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Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. [PDF]
Koban MU+6 more
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U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens [PDF]
Ruthann M. Giusti+12 more
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SLC7A11 frequently migrates faster in SDS‐PAGE. The present study found that the high hydrophobicity of SLC7A11 causes its anomalous migration in SDS‐PAGE with a low concentration of acrylamide gel. Replacing isoleucine with asparagine reduced hydrophobicity and restored its normal migration at 55 kDa, revealing the role of hydrophobicity and gel ...
Nsengiyumva Emmanuel+13 more
wiley +1 more source
Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information. [PDF]
Dijk SW+9 more
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Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology. [PDF]
Kurtin SE, Taher R.
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