Oral Drug Delivery Articles
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Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
7/29/2024
In Part 2 of a two-part series, Fran DeGrazio explains why best practices in particle testing and related risk-based approaches to product quality should not wait for official regulatory guidances and standards to catch up.
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Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
7/29/2024
Regulatory guidance and standards, in official documentation, tend to emerge at a slower pace than do industry best practices. In Part1 of a two-part series, Fran DeGrazio explains why biopharma companies should build and apply best practices in advance of official regulations regarding drug product quality.
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Embrace Packaging and Delivery Systems Designed for Today's Standards
7/1/2024
Regulations and standards for drug delivery systems and packaging are ever evolving and expanding, making it harder and more costly for older products to meet them. In this article, Fran DeGrazio explains why it is imperative that pharma companies consider new product adoption.
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The Key to Regulatory Innovation? Global Harmonization
6/4/2024
Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices.
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Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
5/24/2024
The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.
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New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
5/16/2024
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
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The EU's Ban On TiO2 In Food May Impact Pharma. Here's What You Should Know.
4/18/2024
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
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Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.
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Osmotic Controlled Release Oral Drug Delivery: A Closer Look
2/2/2024
Osmotic controlled release drug delivery is not often spoken about, but it is a useful oral drug formulation technology. This article shares the mechanisms of the elements of oral dosage, including the semi-permeable membrane, pore-forming agents, and more, as well as advantages and applications of this type of drug delivery.
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Liposome Drug Delivery: Global Trends & Market Forecast
1/19/2024
Liposomes possess the ability to encapsulate drugs of both hydrophilic and hydrophobic nature. They can be tailored to target tissues or cells, enabling precise drug delivery. Let's examine how it works, applications, and new market insights.