Articles

Design validation is a critical regulatory requirement, which if done systematically, sets a strong foundation in the success of launching a new medical device to market, while ensuring that the device meets user needs. In the last article “Building a...

Medical device development is a long journey consisting of preliminary bench testing, multiple cycles of ‘build-test-fail-redesign’ and taking the product concept from Research and Development (R&D) to production. Other steps include analyzing the economic environment, getting through clinical trials,...

The development and introduction of new biological drug substances has been on the rise, and so have the regulatory requirements placed on these often life-saving products. At the same time, innovative analytical technologies have been developed that offer new...

Ultra high barrier films protect any dosage content The Pharmaceutical Industry has always mainly focused on novel drug research, formulation development,  and  subsequent  clinical  trials.  As  with  all  other  phases  it  presents  its  own  challenges. There is no use if...

Positron emission tomography (PET) is a popular nuclear imaging technique used to gain information about specific molecular biomarkers. It is often combined with other imaging technologies, such as magnetic resonance imaging (MRI) and computed tomography (CT) scanning, to incorporate...

Implantable drug-eluting devices (DEDs) have come a long way since 1938, when Finland approved a subcutaneously administered birth control device delivering levonorgestrel. Over their development history, the therapeutic performance and value of DEDs has evolved significantly, and recent innovation has...

Innovation is unarguably the essence of pharmaceutical discovery and development. Industry and academia have been working together for decades, but historically relationships did not extend far beyond the traditional exchange of funding and research. There is a risk, however,...