Challenge in Patient Safety

• Potassium Chloride/Citrate (Electrolyte Replenisher): Cardiac arrhythmia is the challenge. We have conducted 11 studies till date
• Buprenorphine (Opioid analgesic): Cardio-respiratory depression is the challenge. We have conducted 3 studies till date.
• Cinacalcet (Calcimimetic): Emesis is the challenge. We have conducted 11 studies till date.

Challenge in Specialized Population

• Specialized populations, pose challenges in conducting BA/BE studies.
• Variability in physiology, metabolism, and drug response within these populations can impact study outcomes.
• Obtaining appropriate sample sizes and recruitment of participants within these populations can be challenging due to limited availability or specific inclusion/exclusion criteria.
• The Factors, such as differences in absorption or metabolism, may require customized study designs and dosage adjustments.
• Close collaboration with healthcare professionals and adherence to ethical guidelines are crucial to ensure participant safety and accurate assessment of BA/BE in specialized populations.
• Despite these challenges, addressing the specific needs and characteristics of these populations is essential to gather reliable data and ensure the safe and effective use of medications.

Challenge in Endogenous Substances

• Endogenous substances, naturally occurring in the body, present challenges in Bioavailability/Bioequivalence (BA/BE) studies. For Example, Study conducted on 100 subjects for Injection Vitamin K. and growth hormone injection study conducted on 40 subjects.
• Determining the bioequivalence of endogenous substances compared to exogenous formulations can be complex due to the presence of endogenous background levels.
• Accurately measuring and quantifying endogenous substance levels in biological samples is crucial but can be challenging.
• Variability in endogenous substance levels within individuals and across different populations can affect study outcomes and interpretation of results.
• Designing appropriate study protocols and selecting suitable reference products that adequately account for endogenous background levels is critical.
• Ensuring sensitive and specific analytical methods to differentiate exogenous substance levels from endogenous ones is essential.
• Robust statistical analysis and interpretation are necessary to account for the inherent variability and establish meaningful bioequivalence assessments for endogenous substances.