ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Impact Of PFAS Regulations On Drug Delivery Devices

  By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.

• Early Decisions To De-Risk The Transition To Combination Products

  The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

• FAQs On The Revised EU GMP Annex 1: Volume 3

  The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

• Advancements In GLP-1 Analog Formulation: Overcoming Challenges

  Oral GLP-1 formulations represent a groundbreaking advance in obesity treatment to offer improved patient comfort and adherence while expanding the therapeutic market.

• Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

  Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.

• Layer By Layer: 3D Screen Printing And The Future Of Drug Development

  3D screen printing can produce tablets across a range of release profiles, from conventional immediate release tablets to multi-compartment drug delivery systems that mix different release profiles.

• Application Of A Novel Temperature Shift Process For Particle Engineering

  Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

• Using 505(B)(2) To Streamline Approval Of Combination Products

  In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

• 4 Most Common Reasons For Medical Device Material Failures

  Material failures in medical devices can have severe consequences for companies. By implementing a proactive design framework , companies can significantly reduce these risks and the associated costs.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.