A review of clinical pharmacology considerations in antibody-drug conjugates approved by the US Food and Drug Administration between 2000 and 2025. [PDF]
Transl Clin PharmacolKoo S +6 more
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Risk of severe infections in patients with triple-negative breast cancer treated with atezolizumab plus nab-paclitaxel: a real-world, postmarketing database study in Japan. [PDF]
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Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend. [PDF]
Clin Pharmacol TherOkami S, Shimotsumagari K, Sadatsuki Y.
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Adverse events associated with full-thickness resection devices in gastrointestinal endoscopy: National postmarketing surveillance study. [PDF]
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Sleep-walking with zolpidem: Need for continued postmarketing surveillance
Indian Journal of Psychological Medicine, 2015 Ajitha Sharma, S Rama Prakasha
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Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments. [PDF]
Clin Pharmacol TherKitagaki H, Takeda K, Murai K, Maeda H.
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Safety Evaluation of Omniscan: An Observational Postmarketing Surveillance. [PDF]
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Characteristics, clinical evidence and implementation effects of conditional approvals for drugs in China, a pooled analysis from 2020 to 2023. [PDF]
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Medication errors and associated serious outcomes in COVID-19 antivirals: a real-world study based on FDA Adverse Event Reporting System database. [PDF]
Ther Adv Drug SafXiong X, Chen Z, Yan B.
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Comprehensive post-marketing safety evaluation of atezolizumab: A disproportionality analysis based on individual case safety reports in the FAERS. [PDF]
PLoS OneCui Y +5 more
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