Medical Device
Reusable Device Cleaning Validation – Three Cycles or One Cycle?
Pacific BioLabs have been performing reusable device cleaning validations for over a decade. Traditionally, PBL has performed cleaning validations by […]
- All
- Analytical Chemistry
- Biologics
- Medical Device
- Microbiology
- News
- Pharmaceuticals
- Toxicology
- Unindexed
Medical Device
FDA Decision to Exempt Certain Class II Devices from 510(k) Premarket Notification
On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet […]
Analytical Chemistry, Toxicology
Maximum Tolerated Dose (MTD) – An effective preclinical dose determination strategy
The path to drug approval involves drug discovery and drug development. In drug discovery, compounds are screened for favorable biological […]
Biologics, Medical Device, Pharmaceuticals
Insulin and Glucagon Bioassays
With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have […]
Medical Device, Pharmaceuticals
USP 661 Plastic Packaging: Introduction to <661.1> and <661.2>
Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may […]
Analytical Chemistry, Pharmaceuticals
CASE STUDY : CHALLENGES IN METHOD DEVELOPMENT FOR DRUG INTERACTION STUDIES
Current FDA guidance indicates that drug interactions should be "defined during drug development, as part of an adequate assessment of the […]
Analytical Chemistry, Medical Device
Detailed Methods for Performing Extractables Testing of Materials
A recent article from the Parenteral Drug Association (PDA) Journal provides some of the best information we have found on […]
Medical Device
FDA Expectations for Reusable Device Reprocessing Validations
In March of 2015, the FDA published a new guidance document titled, Reprocessing Medical Devices in Health Care Settings: Validation […]
Medical Device, Microbiology
Why Understanding Bioburden and Sterilziation is Key to Medical Device Development
Pacific BioLabs and Nutek used to work closely together to perform the microbiology and sterilization needed for medical device sterilization […]
Medical Device
Evaluation of Immunogenicity and Allergic Reactions to Medical Device Materials and Combination Products
As devices become more complex, biocompatibility and material evaluations must necessarily become more complex and thorough as well. Allergic and […]