Fourier-transformed infrared spectroscopy, also known as FTIR, is a method of analyzing both organic and inorganic materials, and can provide a breakdown of their molecular makeup. Using FTIR, one can analyze […]

As you may be aware from our previous blog post, the European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be […]

The European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be enforced starting May 25th, 2020.  This new regulation repeals the […]

The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear dynamic range. In highly complex matrices, the TripleTOF 5600 provides high-resolution of low- abundance analytes which is just […]

The path to drug approval involves drug discovery and drug development. In drug discovery, compounds are screened for favorable biological activity against a target(s) and lead compounds are chosen to […]

Current FDA guidance indicates that drug interactions should be "defined during drug development, as part of an adequate assessment of the drug's safety and effectiveness." 1 While in vivo drug interaction studies […]

A recent article from the Parenteral Drug Association (PDA) Journal provides some of the best information we have found on methods to determine and characterize extractables. It is definitely suggested […]

FDA Registration, New Regulations, and GMP Standards Historically, pharmacies have been able to compound drugs for individual patients or in small batches. These compound pharmacies create and mix drugs customized to […]

  At PBL we hear a lot of questions from medical device clients regarding FDA material and chemical characterization requirements. To address, and hopefully alleviate some of this confusion, we’ll be […]

According to the ICH guideline Q1A(R2) adopted by the FDA and EMA, the goal of stability testing is to demonstrate “how the quality of a drug substance or drug product varies with […]