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Get Prepared for New Plastic Packaging and Manufacturing Materials Requirements

PPD

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

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Article FDA: FDA set to unveil new rule on Laboratory Developed Tests this August

Agency IQ

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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Six Factors for Biotech Companies to Consider When Choosing Next-Generation Contract GMP/CMC Laboratories

PPD

1 With this growth comes increased demands for laboratory services at all steps across the development process. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

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Understanding the Elements of a Typical IND-Enabling Package

The Premier Consulting Blog

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. Primary pharmacology examines the on-target effects on the drug such as receptor binding.

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VIRTUAL TOUR: Discover our In-House R&D and Formulation Laboratories

Alta Sciences

VIRTUAL TOUR: Discover our In-House R&D and Formulation Laboratories tchichekian Tue, 07/11/2023 - 17:49 HTML Enhance Your Outcomes With Our Analytical Services Altasciences’ in-house R&D and formulation laboratories offer an extensive array of analytical solutions to support sponsors’ drug development and manufacturing programs.

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Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively). A call for compassionate opioid overdose response.

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Viral Vectors 101: An Introduction to AAV

addgene Blog

Adeno-associated virus (AAV) is a single stranded, Parvoviridae DNA virus, packaged in a non-enveloped icosahedral capsid, that can be used to express genes of interest in cell and animal models. This post was contributed by guest blogger Didem Goz Ayturk with edits and updates from Addgenies Karen Guerin and Susanna Stroik.

Virus 70