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Standards & Regulation

Business & Regulation Standards & Regulation

Countdown to Cures

| Stephanie Vine

Is pharma keeping up with the latest innovations? US legislators say no, and are looking to a new act to accelerate approvals.

Business & Regulation Facilities

Investigating the de-agglomeration profiles of dry powder inhaler formulations

In this paper, the authors describe the use of laser diffraction to analyse dry powder behaviour.

Business & Regulation Biosimilars

Keeping a Finger on the Biosimilar Pulse

| Fiona Greer

The rise of biosimilars is great news for overburdened healthcare systems, but it’s a very different proposition to a simple generic.

Business & Regulation Drug Delivery

Accelerating the deformulation workflow for oral solid dosage forms

In this white paper we examine the deformulation workflow, demonstrating the value of the technique of Morphologically Directed Raman Spectroscopy (MDRS) within this context.

Manufacture Standards & Regulation

To Err is Human

| Stephanie Vine

But can pharma manufacturers do more to help prevent medication errors?

Discovery & Development Standards & Regulation

Premature Revelation

| Stephanie Vine

FDA scolds company for revealing interim trial results

Business & Regulation Packaging

Personalized Labels

| Stephanie Vine

Just how prevalent is pharmacogenomic information on European drug labels?

Business & Regulation Standards & Regulation

Good Things Come in Small Packages

| Charlotte Barker

Is early and regular dialogue with regulatory agencies the key to success for smaller companies?

Business & Regulation Standards & Regulation

Violation Without Intent?

| Stephanie Vine

Research into rare diseases is on the rise, but are prices sustainable?

Manufacture Standards & Regulation

Beyond Barcodes

| Christian Hay

Serialization will enable our industry to take up its rightful place in the ‘Internet of Things’.

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