New Drug Application (nda) - Infectious Diseases

Relevant Publications

What is needed for the roll-out of psychedelic treatments?

Issue Release: 2024

Characterization of the biological and transcriptomic landscapes of bone marrow-derived mesenchymal stem cells in patients with multiple myeloma.

Issue Release: 2024

Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea.

Issue Release: 2024

Aptamer-Modified NbC Multifunctional Nanomedicine for Targeted Photothermal/Chemotherapy Combined Therapy of Tumor.

Issue Release: 2024

The Black Book of Psychotropic Dosing and Monitoring.

Issue Release: 2024

Branched-chain amino acid transaminase 1 confers EGFR-TKI resistance through epigenetic glycolytic activation.

Issue Release: 2024

A Sponsor\'s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan.

Issue Release: 2024

Development of a 2D-QSAR Model for Tissue-to-Plasma Partition Coefficient Value with High Accuracy Using Machine Learning Method, Minimum Required Experimental Values, and Physicochemical Descriptors.

Issue Release: 2023

Retrospective analysis of the biopharmaceutics characteristics of solid oral Modified-Release drug products in approved US FDA NDAs designated as Extended-Release or Delayed-Release formulations.

Issue Release: 2023

Acute Encephalopathy Due to Polypharmacy Interactions With the Use of Paxlovid: A Case Report.

Issue Release: 2023

Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019-2023) by US FDA, best practices and recommendations.

Issue Release: 2023

Leveraging GPT-4 for Food Effect Summarization to Enhance Product-Specific Guidance Development via Iterative Prompting.

Issue Release: 2023

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019.

Issue Release: 2023

Drug Development for New Psychiatric Drug Therapies.

Issue Release: 2023

Avasopasem for the treatment of radiotherapy-induced severe oral mucositis.

Issue Release: 2023

Twenty-five years of novel drug approvals in rheumatology.

Issue Release: 2023

The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application.

Issue Release: 2022

Trends and Characteristics of New Drug Approvals in China, 2011-2021.

Issue Release: 2022

Prospective F-18 FDOPA PET Imaging Study in Human PD.

Issue Release: 2022

Exploring Drug Patent Linkage and the First ANDA Litigation in China.

Issue Release: 2022

What are Direct Acting Antivirals (DAAs)?

What Do Blood Test Results Mean?

What Are Emerging Bacterial Threats?

What are Apicomplexan Parasites?

What Are the Common Types of Infectious Diseases?

What are Sexually Transmitted Infections?

Why Are Functional Assays Important?

What are Antipyretics?

Why Is Aedes Aegypti So Efficient at Spreading Diseases?

What are the Technological Advances in Genomic Sequencing?

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