Safety testing is a crucial part of drug development and is dictated by pharmacopoeial guidelines, which must be followed when performing each step of the process. Ideally, the method development stage is when any potential sample preparation problems are resolved to make the routine analysis easier; however, depending on the product in question, this can become a lengthy process as preparation methods can vary broadly. John McKenzie PhD, FRSC Chief Executive Officer at Wickham Laboratories Ltd looks at risks, regulations, and considerations.