Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability...
In globalising the pharmaceutical industry oversight and control has increasingly become a challenge in managing product quality, consumer safety and organisational risk.
Down at the base of Africa is a country with amazing heritage, unique geography, and challenging patient populations. See why clinical trials happen in South Africa here
In an industry that is seeing increasing levels of outsourcing, the contract research organisation (CRO) needs to have proven experience in both the pragmatism and flexibility of method development and a regulatory background in validation.
Getting a clinical trial drug into China is a complex business. Any discrepancies in paperwork or the physical shipment can lead to delays at customs or China Inspection & Quarantine. World Courier shares its experience for successful shipping.
During a manufacturing process unexpected and unknown impurities may arise in a sample. It is important that such impurities are isolated and identified.
The nature and scope of clinical research has changed significantly over the past decade. Studies are more complex, globalized and patient-centric than ever. Yet, the processes used to package and ship study drugs to trial sites are stuck in an earlier...
As the deadline for drug serialization in the EU looms closer, it’s time to put the topic firmly on your agenda. Learn how to overcome the serialization challenge and simplify compliance.
