Industry Webinar
6 Nov 2025
BCS-Based Biowaivers: Streamlining Bioequivalence Assessment Through in Vitro Approaches
The Biopharmaceutics Classification System (BCS) enables the scientific and regulatory framework for granting biowaivers of in vivo bioequivalence studies. By categorizing drug substances according to solubility and permeability, the BCS allows the substitution of traditional clinical trials with validated in vitro testing. Recent regulatory guidance, including ICH M9 and EMA’s reflection paper (CHMP/QWP/708282/2018), outlines the requirements and limitations of this approach, fostering both efficiency and patient-centric development. BCS-based biowaivers significantly reduce the ethical and financial burden of unnecessary human studies, while maintaining rigorous quality and safety standards. This presentation will highlight the principles of BCS classification, testing strategies, and the regulatory criteria for eligibility. Case examples will demonstrate how in vitro data support formulation optimization, lifecycle management, and global regulatory submissions. Ultimately, the BCS framework offers a science-driven, harmonized path to accelerate market access and ensure consistent product performance.
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Chelab
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Country/Region:Italy
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On CPHI since:2020
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Certificates:4
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Employees:1000 - 4999
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Other Content from Chelab (12)
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News Merieux NutriSciences approach | Nitrosamine alert
Mérieux NutriSciences' approach to addressing the global nitrosamine alert incorporates several innovative elements that significantly advance current solutions on the market, with promising implications for future developments in the pharmaceutical industry. -
Brochure Mérieux NutriSciences | Pharma Service Catalogue
Pharmaceutical Laboratory Services - One-stop shop pharma facility.
Mérieux NutriSciences is a valued partner to the global healthcare industry, offering research, development and quality control testing of pharmaceutical products.
From active ingredients to finished products, we offer a complete range of analytical and research services for API and pharmaceutical products.Our services include safety and quality control, development and validation of analytical methods. Our fully equipped, state-of-the-art laboratories offer comprehensive testing services according to the current pharmacopoeia. We also provide tailored solutions according to customer specifications.
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News Merieux NutriSciences | Passepartout Studies
We are excited to introduce our Passepartout Studies, a revolutionary approach to extractables profiling for pharmaceutical packaging.
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Brochure Merieux NutriSciences | Nitrosamines analysis
Thanks to the long-standing experience, Mérieux NutriSciences has been developing various strategies and approaches for the determination of nitrosamines residues in different matrices through sophisticated mass spectrometry combined with a pool of experts.
Our capabilities: The R&D department of Mérieux NutriSciences | Pharma and Healthcare has developed and/or validated high sensitive methods suitable for more than 70 NDRSIs and small nitrosamines. -
Brochure Mérieux NutriSciences | Viral Clearance
Our capabilities - The Viral Clearance Study
Our dedicated virology lab control the viral safety of your product by assessing the capacity of the production processes to clear infectious viruses. The objective of viral clearance studies is to evaluate the ability of the manufacturing process to inactivate/remove known or even unknown viral contaminants, and to estimate process robustness by characterizing its ability to clear different model viruses. -
Brochure Mérieux NutriSciences | Extractables and Leachables studies
Mérieux NutriSciences performs E&L studies providing a full integrated testing strategy together with toxicological assessment and risk analysis.
Extractables and Leachables studies provide a full-integrated testing strategy together with toxicological assessment and risk analysis, in six main steps:Profiling of extractables: generation of the extractCharacterization of extractablesPrimary and secondary leachables profileUnknown extractables/leachables tentative identification by HRMS techniques (if needed)Toxicological evaluation and risk assessmentDevelopment and validation of targeted methods suitable for the quantification of critical leachables -
Brochure Mérieux NutriSciences | Foreign particles identification
The presence of foreign particles in sterile pharmaceutical products and/or medical device can affect their safety and efficacy.Foreign particles may originate from both organic and inorganic sources, as corroded or damaged equipment parts, cross contamination during the process, microplastics or from biological sources. The implementation of quality controls for particles can be a good strategy in order to minimize the contamination probability.
Mérieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentations combined with a pool of experts in different fields. -
Industry Webinar Safety as a Tool of Sustainable Innovation: How the New PPWR May Affect the World of E&L
The EU new regulation on packaging and packaging waste has recently been approved, and novel perspectives on packaging sustainability – including end-of-life pathways – could impact more or less directly also the pharmaceutical and medical fields. Can we assess the potential impact of these changes from an analytical perspective in chemical characterization testing and E&L? How can the analytical approach evolve in order to deal with packaging made of recyclable, recycled, biodegradable materials? What technical evaluation and technical standards would need to be referred to with regards to recycling, reuse, content of recycled materials, and compostability/biodegradability? -
Industry Webinar Nitrosamines & Nitrites in Pharmaceuticals: From Regulatory Updates to Analytical Solutions
The control of nitrosamines and nitrites in pharmaceuticals remains a critical challenge for MAHs, API manufacturers, and regulatory bodies worldwide. Recent updates from EMA and FDA guidance have expanded the scope from small nitrosamines to nitrosamine drug substance-related impurities (NDSRIs), imposing stricter requirements for risk assessments, confirmatory testing, and dossier compliance. Analytical complexities arise from trace-level detection, artefact formation, and matrix interferences, demanding advanced mass spectrometry and robust method validation. Nitrites, ubiquitous in excipients and raw materials, represent a key root cause of in situ nitrosamine formation and require systematic monitoring. This presentation will explore state-of-the-art analytical approaches, including LC-MS/MS, HRMS, ion chromatography, and NAP test applications, alongside case studies on sensitivity, specificity, and robustness. -
Brochure Merieux NutriSciences | Absorption and Efficacy in vitro studies
In vitro models mimic the different biological barriers and target organs by which it is possible to evaluate absorption and efficacy of formulations.
Absorption studies permit the performing of several screening tests to preliminarily evaluate products, ingredients or formulations before proceeding with the next steps evaluation. -
Brochure Merieux NutriSciences | Novel Food: the entire value-chain in our labs
Mérieux NutriSciences supports you from the initial assessment of your project to the correct identification of the requirements for submitting the dossier to the Commission.We perform all the necessary tests in our labs,and apply for Novel Food authorisation. -
Brochure Merieux NutriSciences | Medical Devices: innovative Solution for the Healthcare
Thanks to a valuable pool of experts, Mérieux NutriSciences supports you in the development of the testing plan to determine which studies are necessary to ensure that the device is safe and effective, meeting the essential requirements for affixing the CE mark on the product.Regulatory support and Risk AssesmentQuality Controls and StabiltyBiocompatibilityAbsorption and efficacy studiesHuman factor services