Newsletter | August 1, 2023

08.01.23 -- How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals?

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FEATURED EDITORIAL

How Predictive Can Regulatory Drug Abuse Potential Investigations Be In Animals?

Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance, Non-clinical Investigation of the Dependence Potential of Medicinal Products, in 2006, and the FDA guidance, Assessment of Abuse Potential of Drugs, in 2010, have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.

INDUSTRY INSIGHTS

Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

Combination therapies delivered directly to the lung by dry powder inhalants can help reduce patient burden. Explore case studies illustrating the potential for improving care for critically ill patients.

Chromatography Method For Purifying Infectious Virus Particles

This application note demonstrates a chromatography method for purifying reovirus RNA virus particles using a benchtop chromatography system, HiTrap brand columns, and Capto brand Core 700 resin.

Scale-Up And Site Transfer Of A Semi-Solid Product For Commercial Launch

Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product.

Increasing Spray-Drying Throughput For Brick Dust Compounds

Brick dust compounds require additional steps if spray drying is to yield a commercially attractive process. Explore technologies designed to improve drug solubility in organic solvents for spray drying.

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HanchorBio Announces Taiwan FDA IND App For The Multi-Regional Clinical Trial Of HCB101

A Closer Look At Sinoveda's Technology For Developing Combination Drugs

ImmunoGen Announces Multi-Target License & Option Agreement With ImmunoBiochem

MD Anderson & Nexo Therapeutics Announce Strategic Research Collaboration

Nectero Medical Receives FDA IND Clearance To Initiate Phase II/III Clinical Trial Of Nectero EAST

SOLUTIONS

Container Closure Integrity Testing

CHO Platform Service Package For Biopharmaceutical Cell Line Development

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