Factors in Developing Injectable Drug Placebo Formulations for Pharmaceutical Clinical Trials

Placebo-controlled trials are pivotal in assessing the efficacy of newly developed medicines, serving as a gold standard in clinical research. When meticulously crafted and executed, these trials offer compelling evidence of a drug's effectiveness. A fundamental aspect contributing to the success of such trials lies in the formulation of placebos…

Specializing In Small And Early-Stage Injectables, Not Just Small Batches

Source: Singota Solutions Navigating the complex landscape of pharmaceutical development (Injectables), particularly for small and early-stage companies, demands careful consideration of manufacturing partnerships. While large CDMOs may seem like obvious choices, their focus on high-volume production often leaves smaller projects sidelined. This shift is notable in the context of the industry's…

Deliver A Technical Package That Serves On-Time Injectable Project Completion

Source: Singota Solutions By William Powers, Singota Solutions Meeting drug development timelines — in particular, filling the first Phase 1 batch for an injectable’s clinical trial – is critical. Producing that initial batch requires the CDMO to gather information from a pharmaceutical client about its drug substance, drug product, and analytical…

Analysis Paralysis: Navigating Early-Phase Analytical Validation

Source: Singota Solutions By Dustin Lafferty, Singota Solutions Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.…

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