Labeling And Dosing - Pharma

Relevant Publications

Population Pharmacokinetics (PopPK) Support for Pediatric Dosing of Biological Products.

Issue Release: 2024

US FDA\'s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies.

Issue Release: 2024

Real-world use, dose intensity, and adherence to enfortumab vedotin in locally advanced or metastatic urothelial cancer.

Issue Release: 2024

Pediatric Beta Blocker Therapy: A Comprehensive Review of Development and Genetic Variation to Guide Precision-Based Therapy in Children, Adolescents, and Young Adults.

Issue Release: 2024

Observation and Characterization of Vibrationally Active Surface Species Accessed with Nonthermal Nitrogen Plasmas.

Issue Release: 2024

Unlicensed antiviral products used for the at-home treatment of feline infectious peritonitis contain GS-441524 at significantly different amounts than advertised.

Issue Release: 2024

Mathematical Modeling Unveils Optimization Strategies for Targeted Radionuclide Therapy of Blood Cancers.

Issue Release: 2024

Low-Dose Infigratinib Increases Bone Growth And Corrects Growth Plate Abnormalities In An Achondroplasia Mouse Model.

Issue Release: 2024

Assessment of Dosing Strategies for Pediatric Drug Products.

Issue Release: 2024

Remdesivir Discontinuation Decisions Based on Thresholds of Aminotransferase in an Observational Registry.

Issue Release: 2024

Parenteral Beta-Lactam/Beta-Lactamase Inhibitor Ordering in Hospitals That Provide Care for Pediatric Patients.

Issue Release: 2024

Exposure-Response Analyses for Belzutifan to Inform Dosing Considerations and Labeling.

Issue Release: 2024

Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?

Issue Release: 2024

Effects of behavioral interventions on stress reactivity in adults with substance use disorders.

Issue Release: 2024

Use of Stable Isotope Labeled (SIL) Antibodies in Cassette Dosing to Improve Pharmacokinetics Screening Efficiency of ADCs with Novel Cytotoxic Payloads.

Issue Release: 2024

Quantifying protein kinetics in vivo: Influence of precursor dynamics on product labeling.

Issue Release: 2024

Evaluating Common Ingredients Contained in Dietary Acne Supplements: An Evidence-Based Review.

Issue Release: 2024

Mathematical Modeling Unveils Optimization Strategies for Targeted Radionuclide Therapy of Blood Cancers.

Issue Release: 2024

\"Getting the Dose Right\"-Revisiting the Topic With Focus on Biologic Agents.

Issue Release: 2024

Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in Pediatric Recipients of Heart or Liver Transplants: A Regulatory Perspective.

Issue Release: 2024

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