This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed. Highly potent drugs exhibit a combination of high toxicity and therapeutic efficacy at low ...

The development of drugs has brought about a revolution in human health. Guided by pharmacology and clinical sciences, and driven by chemistry, pharmaceutical research in the past has played a crucial ...

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods. The bio/pharmaceutical industry has seen the development of a variety of emerging therapies, ...

An analytical review in accounting is used by auditors to assess the reasonableness of account balances. Examples of analytical reviews of financial statements broadly include vertical and horizontal ...

An overview of trends in gene therapy, the unique analytical challenges posed by developing new treatments, and innovative solutions to address these challenges. Drug development is rapidly evolving, ...

Intimate Connectivity Must Be Maintained Throughout the Product’s Lifecycle The link between product specifications and analytical methods throughout a product’s lifecycle makes intuitive sense. One ...

In this interview conducted at Pittcon 2024 in San Diego, we spoke to Professor Jonathan Sweedler about moving through his career as an analytical chemistry faculty member. Could you please introduce ...