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.
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 : Managing healthcare transformation towards personalized, preventive, predictive, participative precision medicine ecosystems
Bernd Blobel, University of Regensburg, Germany
Title : Analytical strategies for solid-state forms in drug development
Maria Cristina Gamberini, University of Modena e Reggio Emilia, Italy
Title : Understanding drug transport in plasma: The role of protein binding
Saad Tayyab, UCSI University, Malaysia
Title : Innovative development and delivery of biologics for chronic obstructive pulmonary disease
Yong Xiao Wang, Albany Medical College, United States
Title : Search for novel biomarkers and therapeutic targets for inflammatory disease
Madhav Bhatia, University of Otago, New Zealand
Title : Personalized and Precision Medicine (PPM) as a unique healthcare model through de-sign-inspired biotech- & biopharma-driven applications and upgraded business mar-keting to secure the human healthcare and biosafety
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, 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 AutĂłnoma de Baja California, Mexico
Title : Abuse-deterrent dosage form technique utilizing a fusion of innovative pharmaceuticals and ion exchange resin
Bhupendra Gopalbhai Prajapati, Parul University, India
Title : Macitentan/tadalafil combination– An additional value in pharmacotherapy of pulmonary arterial hypertension
Miroslav Radenkovic, University of Belgrade, Serbia