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Standards & Regulation

Business & Regulation Facilities

Keep It Clean

| Stephanie Vine

The technology behind cleanrooms is well over 50 years old. Is it time for a makeover?

Business & Regulation Business Practice

Too Close for Comfort?

| James Strachan

Researchers call for more oversight as some pharma companies cozy up to hemophilia patients.

Business & Regulation Business Practice

Made in China

| James Strachan

The world’s most populous state is set for big things in patented (bio) pharmaceutical development.

Manufacture Quality & Compliance

Turning Failure into Success

| Stephanie Vine

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Business & Regulation Packaging

Insights into Elemental Impurities

| Dennis Jenke

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

Business & Regulation Standards & Regulation

Shaking Up European Drug Prices

| Stephanie Vine

Will future drugs in Europe be priced based on therapeutic outcomes?

Business & Regulation Clinical Trials

Failure to Launch

| James Strachan

How difficult is it to develop a new drug? Statistics have the answer

Business & Regulation Clinical Trials

Clinical Trials in Safety Spotlight

| James Strachan

The EMA says it will review its standards for first-in-human trials

Discovery & Development Business Practice

Combining spectroscopy: a new approach to meeting new pharmaceutical challenges

Automated image analysis has been combined with Raman spectroscopy to achieve component-specific size and shape analysis of active ingredients, supporting and accelerating the commercialization of both innovator and generic pharmaceutical products.

Business & Regulation Business Practice

Helping or Hindering Science?

| Michael Merrifield, Chris Leigh

Astronomers Chris Leigh and Mike Merrifield debate how a potential Brexit might impact UK science

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