Biowaivers play a pivotal role in the realm of biopharmaceutics, offering a streamlined approach to drug development and regulatory approval. These waivers are essentially a scientific justification for exempting in vivo bioequivalence studies, relying instead on in vitro methodologies and comprehensive data analysis. By leveraging biowaivers, pharmaceutical companies can expedite the approval process, reduce costs, and allocate resources more efficiently.
Biopharmaceutics, at its core, explores how the body interacts with drugs, emphasizing factors like absorption, distribution, metabolism, and excretion. Biowaivers demonstrate a sophisticated understanding of these processes, allowing for a more targeted and personalized approach to drug development. This innovative approach not only accelerates the availability of essential medications to the market but also fosters a more sustainable and cost-effective pharmaceutical industry.
In the era of precision medicine, biowaivers exemplify a strategic shift towards optimizing drug development methodologies. By harnessing the power of biopharmaceutics, researchers and regulators alike can navigate the complex landscape of drug approval with greater efficiency and scientific rigor, ultimately benefiting patients worldwide.
Consolato M Sergi
Universities of Alberta and Ottawa, Canada
Vladlen Slepak
University of Miami Miller School of Medicine, United States
Andreas M Papas
Antares Health Products, United States
Sergey Suchkov
The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian FederationSubmit your abstract Today
Title : Medical liver biopsy: Toward a personalized approach
Consolato M Sergi, Universities of Alberta and Ottawa, Canada
Title : Macitentan/tadalafil combination– An additional value in pharmacotherapy of pulmonary arterial hypertension
Miroslav Radenkovic, University of Belgrade, Serbia
Title : Ectopically expressed olfactory receptors as an untapped family of drug targets and discovery of agonists and antagonists of OR51E1, an understudied G protein-coupled receptor
Vladlen Slepak, University of Miami Miller School of Medicine, United States
Title : Mathematical modeling the disc diffusion test: Antibacterial activity of copper-doped SnO2
Paulo Cesar De Morais, Catholic University of Brasilia, Brazil
Title : Emerging formulation and delivery applications of Vitamin E TPGS
Andreas M Papas, Antares Health Products, United States
Title : The promise of nanotechnology in personalized & precision medicine: Drug discovery & development being partnered with nanotechnologies via the revolution at the nanoscale
Sergey Suchkov, The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian Federation
Title : Personalized and Precision Medicine (PPM) as a unique healthcare model through design-inspired biotech- & biopharma-driven applications and upgraded business marketing to secure the human healthcare and biosafety
Sergey Suchkov, The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian Federation
Title : Design and evaluation of exo-itc: A bilayer fibrous system for controlled exosome delivery in dermatological applications
Luis Jesus Villarreal Gomez, FCITEC - Universidad Autónoma de Baja California, Mexico
Title : Antibody-proteases as translational tools of the next-step generation to be applied for biopharmacy-related and precision medical practice
Sergey Suchkov, The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian Federation
Title : Understanding drug transport in plasma: The role of protein binding
Saad Tayyab, UCSI University, Malaysia