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Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials
The cost of bringing a new drug to market has grown significantly over the past decade, therefore the investment for biopharmaceutical company’s success is critical. During a clinical trial it is vital to ensure superior efficacy and safety when compared to an existing commercial product.
Having examined the physiochemical properties of the API and market requirements for the drug product and decided upon a capsule dosage form for clinical trial supplies, a sponsor would also consider blinding or masking when developing their protocol design.
This integral part of blinding can help remove both investigator and patient bias due to the visibility of the marketed product and can limit a potential placebo effect. Over-encapsulation of tablets or capsules is one of the most extensively used processes available to sponsor companies to promote blinding.
During this on demand webinar session, speakers involved will utilise their experience in the industry to explore the various mechanisms and techniques currently available in the marketplace, including capsule blinding, to promote successful clinical trial supply capsule manufacture and over-encapsulation. They will also discuss key GMP challenges that need to be overcome in order to ensure product quality and study result integrity.
Watch this webinar to gain insight into:
- Impact & Requirements of GMP / Annex 13
- Preparation of blinded investigational medicinal products
- Evaluation of capsule manufacturing techniques and technologies
- The importance of analytical assessment
- Real life clinical case study
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