Formulation Development Featured Articles
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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
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4 Focus Areas To Expand The Success Of Antibody-Drug Conjugates
2/9/2023
Antibody-drug conjugates (ADCs) represent a significant advance in therapeutic engineering. They combine an antibody, a linker, and a payload designed into a single molecule for delivery to a specific target. Why do discontinuation rates remain high, and what are the novel strategies that we as drug developers can use to maximize success?
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AI/ML In Drug Discovery & Development: Potential And Challenges
1/11/2023
Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.
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FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
1/11/2023
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
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The Need — And Opportunity — To Develop Broad-Spectrum Antivirals
1/3/2023
One factor contributing to the lack of broad-spectrum antivirals is a lag in testing technology for viruses. This article discusses interferons (a group of signaling proteins secreted by cell types to coordinate the body’s natural antiviral responses) and other potential broad-spectrum antivirals, as well as the new testing initiatives being conducted.
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6 Drug Discovery Learnings From The Lab
10/5/2022
With more than 25 years of experience, this author shares insights from the perspective of bench science that pertain to experimental design and data generation. These concepts apply not only to individual experiments but also more broadly.
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Is Phage Therapy Ushering In A Post-Antibiotic Era?
10/3/2022
Faced with the emergence of resistant bacteria, phage therapy, which uses bacterial viruses (bacteriophages) to treat bacterial infections, is emerging as one of the most credible alternatives to antibiotics.
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The Key Enablers Of Late-Phase Biologics Development And Launch
9/27/2022
Dr. Claudia Müller answers questions from a webinar about the complex path to a successful product launch, which requires a holistic development strategy driven by a well-defined target product profile.
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Taste Masking 101: A Q&A With The Experts
8/19/2022
There are several taste masking strategies drug developers can implement to improve a drug’s palatability and increase its potential for greater patient adherence.
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Your 3-Step Process For Innovation In Precision Medicine
8/3/2022
Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts?