The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has ...

It is not uncommon for inventors to want to attempt to draft and file patent applications on their own, and I frequently get asked about sample patent applications. Here is where you as an inventor ...

The IRS has provided procedures (Rev. Proc. 2018-60) under which a taxpayer may obtain automatic consent to change a method of accounting to comply with Sec. 451(b), as amended by the law known as the ...