The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives. The US Food and Drug Administration's Office of Generic Drugs (OGD) and ...

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

Customers enjoy buying from a small business that consistently delivers great products. However, the experience may last only a short time: Only two out of four small businesses survive beyond five ...

In the past 10 years, the pharmaceutical industry has been moving towards a design space approach to development and manufacture – an approach that has been defined by ICHQ8, Q9 and Q10, and the ...

The biotechnology and pharmaceutical industries must adapt to new advancements to develop new therapies for patients with unmet needs. In this exciting time, there are a range of advanced modalities ...

A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...