Ensuring a Carefully Designed and Executed Product Packaging Interaction Study for Concise Cost-Effective Evidence in Support of New Drug Product Development

Apr 11, 2017

The US Food and Drug Administration (FDA) Guidance for Industry document ‘Container Closure Systems for Packaging Human Drugs and Biologics’, addresses the review and evaluation of packaging requirements. According to this document, each new drug application (NDA) or abbreviated new drug application (ANDA) should contain sufficient information to demonstrate that a proposed container closure system and its components are suitable for its intended use. Last, but not least, Mike Ludlow, Technical Study Manager, CMC Analytical Services at LGC, focuses on product packaging and new drug development. ...

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The Advent of Patient-centricity: What Does it Actually Mean?

Apr 11, 2017

There is a lot of buzz in the pharmaceutical and healthcare industry right now around the concept of ‘patientcentricity’. The term can mean many different things to a lot of different factions within the healthcare space. With high-profile headlines about drug pricing in the market, the industry is coming around to the enlightening thought that it ought to be more overtly focused on the patient. Justin Schroeder, Executive Director, Marketing, Business Development & Design at PCI Pharma Services explains this is now borne out in many facets of the business. ...

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Innovative Glass Production for Pharmaceutical Packaging

Apr 11, 2017

Why is glass still the first choice of primary packaging for most pharmaceuticals today and how much high-tech do you need to manufacture a glass container that has good filling properties and keeps the content safe? IPI Media Director, Anthony Stewart, visits Gerresheimer`s pharmaceutical glass facilities in Lohr and Wertheim, and learns the process of the company’s high-quality glass manufacturing. ...

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Serialisation – Commercial Versus Clinical Perspectives

Jan 8, 2016

There is a significant amount of activity in the pharmaceutical industry in mobilising to meet the requirements of recent Drug Quality and Safety Act (DQSA) legislation, passed by the United States Congress with the intention of limiting the spread of counterfeit or otherwise falsified medicines to patients for prescription drug products. Justin Schroeder, Executive Director, Marketing, Business Development & Design at PCI Pharma Services (PCI), reviews serialisation from the perspective of commercial versus clinical. ...

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Relating Tamper-evident Technology to Market and Product Fraud Risk

Jan 8, 2016

To make a pharmaceutical folding box tamper-evident may be as simple as taping the flaps. This method will reduce some less severe types of fraud, such as taking a blister out of the box, at a shop or warehouse, without notice. However in high-risk environments, fraudsters may elaborate fancy methods to harvest even security- sealing labels on original packaging for reuse. Dr Marietta Ulrich-Horn at Securikett, together with devoted clients, works on a systematic approach to close the loopholes in tamper-evident technology. ...

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