Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials
The cost of bringing a new drug to market today is estimated to be in the region of $1 billion – a significant investment for biopharmaceutical companies therefore making it critical from the outset 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 interactive 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
Almac Pharmaceutical Drug Product Development
Addressing the increasing pressure on pharmaceutical companies to bring clinical candidates through their pipeline faster and with greater efficiency, Almac Pharma Services provide expert pharmaceutical drug product development solutions.
Our scientists can develop clinical candidates into optimum formulations and manufacture solid oral dose products for all stages of clinical trials.
From developing a fit-for-purpose formulation for First-in-Human trials, to scaling up for late phase trials.