Dear Fellow Pharmaceutical Scientists; I am pleased to invite you all to the May 2024, Bioequivalence and Bioavailability Sciences community on May 01, 2024. We are fortunate that Dr. Diana Vivian and Dr. Angelique Besold agreed to speak on two important topics. Please plan on attending this interesting webinar and I request each one of you to circulate this announcement among your peer groups and interested colleagues. Bioequivalence Bioavailability Sciences Community May 1, 2024, webinar May 1, 2024, 11:00 AM – 12:00 PM (America/New York) Topic 1: “ Complex Generic Drug Product Changes: Bioequivalence Considerations and Case Studies” Speaker: Dr. Diana Vivian, Associate Division Director, Division of Bioequivalence II, USFDA Abstract: Recommendations for data needed to support changes to complex generic drug products are generally not covered in published Scale-Up and Post Approval Changes (SUPAC) guidances. This talk will highlight case studies of previous considerations and recommendations for complex generic drug product changes. Topic 2: “ Overview of FDA’s Scale-up and Post-Approval Changes (SUPAC) Guidance Perspectives” Speaker: Dr. Angelique Besold , Pharmacologist, Division of Bioequivalence II, USFDA Abstract: This talk outlines the current bioequivalence recommendations for studies to be submitted to the FDA for post-approval changes made to immediate release and modified release solid oral dosage forms. Mark your Colanders and join the webinar on May 1, 2024, using information given below Bioequivalence Bioavailability Sciences Community May 1, 2024, webinar May 1, 2024, 11:00 AM – 12:00 PM (America/New York) Please join my meeting from your computer, tablet or smartphone. https://meet.goto.com/141602341 You can also dial in using your phone. Access Code: 141-602-341 United States: +1 (571) 317-3122 Join from a video-conferencing room or system. Meeting ID: 141-602-341 Dial in or type: 67.217.95.2 or inroomlink.goto.com Or dial directly: [email protected] or 67.217.95.2##141602341 Get the app now and be ready when your first meeting starts: https://meet.goto.com/install
There has been strong and increased interest in twin-screw melt granulation (TSMG) for solid oral dosage forms. TSMG relies on the dispersive and distributive mixing at the kneading zone for granule formation and growth. Therefore, proper design of kneading elements plays a predominating role in the success of TSMG. Despite extensive research conducted on the impact of screw geometry in melt compounding, there has been limited literature for TSMG in pharmaceutical applications. Disc width for the kneading elements used in TSMG was 2 mm, contrary to the standard 5 mm used in other melt compounding processes. Considering that overflight clearance (OC) and disk width (DW) are the two key geometrical parameters that define the mixing dynamics when the formulation blend passing through the kneading elements, the main focus of our research is to elucidate the impact of varying OC and DW on the granule properties during TSMG. We found that the new elements we designed did reduce the peak shear at kneading zone. However, a higher barrel temperature and degree of fill (DoF) are required to compensate for that change in order to attain similar granule attributes. Our study showed the higher DoF was achieved through a combination of modified screw configuration with pre-densified powders that allowed the kneading and processing to occur at a lower screw speed. On the other hand, process optimization was explored as an approach to minimize the impact of higher barrel temperature to drug stability. A thermally unstable drug, gabapentin, was utilized as a model for this process optimization study. Using the new kneading elements, compressible granules (Tensile strength > 2 MPa) with low % GABA-L content were manufactured successfully despite increasing OC to 0.4 mm. Granules obtained were stable at 40 C and ambient humidity up to 6 months, indicating gabapentin was stable (% GABA-L ≪0.4 %) despite a high barrel temperature of 120 C. In conclusion, the overflight clearance (OC) and disk width can be optimized to successfully melt-granulate even the thermally non-stable drugs.
Significant advances in nucleic acid therapeutics, including the use of mRNA vaccines for COVID-19, have spurred new interest in the use of lipid nanoparticles (LNPs) especially for extrahepatic delivery. In this presentation, I will cover our work on utilizing endogenous mechanisms for targeted delivery of nucleic acid therapeutics. Specifically, I will cover on the role of protein corona formed on LNPs, myeloid cell uptake of LNPs and selective tropism towards disease sites, and secretion of extracellular vesicles and their ability to amplify transfection through a bystander effect. Learning Objectives: Specific approaches for targeted nucleic acid delivery using lipid nanoparticles (LPNs) and specific emphasis on endogenous mechanisms. The role of tailored protein corona composition on LNPs and potential for extrahepatic delivery. Using myeloid cells as Trojan Horse in LNP-mediated transfection and therapeutic benefits for treatment of inflammation and cancer.
Monthly meeting for AAPS Global Health Community Leadership All members of the Global Health Community welcome to attend to learn more, volunteer for specific items, influence the direction of activities! Please join meeting from your computer, tablet or smartphone. https://meet.goto.com/471580205 You can also dial in using your phone. Access Code: 471-580-205 United States: +1 (872) 240-3311 Join from a video-conferencing room or system. Meeting ID: 471-580-205 Dial in or type: 67.217.95.2 or inroomlink.goto.com Or dial directly: [email protected] or 67.217.95.2##471580205 Get the app now and be ready when your first meeting starts: https://meet.goto.com/install
MAY 13-16, 2024 HILTON SAN FRANCISCO UNION SQUARE, SAN FRANCISCO, CA
Dear Community, on the same week of the 2024 # AAPSNationalBiotechnologyConference there will be an evening reception and a webinar with Julie Suman and Irene Rossi as speakers. The event is in person only and you can find all the details in the flyer. Register at the link: https://www.aaps-badg.org/lrene If you have the chance, take part because it will be great! We want to warmly thank the sponsors Septerna and Genentech for supporting the event. #inhlation #Nasal #drugdelivery #Inhalation
In 2019 USP created an Expert Panel (New Advancements in Product Performance Testing) to do a gap analysis on the need for and possible creation of tests/standards for measuring the performance of drug products. The results of Working Groups within the Expert Panel have been presented in a series of articles in Pharmacopeal Forum and Dissolution Technology. The purpose of this webinar is to present to stake holders and interested members of the pharmacy community, the findings of the Working Group dealing with inhalation and nasal products and allow for questions and suggestion from participants for improvement/modifications for the Working Group’s findings. Learning Objectives: • Understand the role of stimuli article as opposed to Official or Informational Chapters in the United States Pharmacopeia (USP). • Describe the process used by the USP Expert Panel to identify existing tests, gaps and challenges involved in drug performance testing. • Evaluate the findings of the Working Group addressing inhalation and nasal products as presented in the stimuli article. • Question and provide input to the findings of the Inhalation and Nasal Working Group.
Register for this webinar!! Four great experts in the field will be together for an interesting webinar on the development of inhaled biologics. John Patton, Keith Ung, Andy Clark and Jeff Weers will make us travel in the current and future trends, opportunities and considerations for the development of inhaled biologics.
JULY 22-25 KANSAS CITY, MO The AAPS Summer Scientific Forum makes AAPS the premier scientific convener of the pharmaceutical industry: breadth, depth, and quality science. Attend this meeting for depth in the latest bioanalysis or pharmaceutical analysis science and seize the opportunity to cross-connect with other scientists in shared high-level sessions focused on key regulatory issues facing these scientific areas.
Antibody drug conjugates (ADCs) are revolutionizing the pharmaceutical industry. This emerging modality comes with the promise of targeted therapy with increased precision and selectivity therefore enhancing the overall therapeutic index. ADCs, by nature, have characteristics of both antibody therapeutics and small molecules, posing a unique challenge for the field of PK/PD and clinical pharmacology. In this webinar, we bring top scientists of the field to introduce how the concepts of PK/PD and clinical pharmacology are being applied to support discovery and development of ADCs. Specific focus will be given to model-informed drug discovery and development. The first part of the webinar will cover how the different pieces of PK/PD data can be brought together with quantitative systems pharmacology (QSP) modeling to aid the preclinical to clinical translation of ADCs. It will showcase how the complexity of the ADC modality can be characterized for its PK/PD and how the different data can be integrated with the approach of QSP modeling and simulations. The second part of the webinar will focus on clinical development of ADCs. Industry examples will be presented on dose selection and justification during clinical development that were supported by population pharmacokinetic modeling and exposure-response analysis. It will demonstrate how the complex challenges associated with unique characteristics of ADCs were tackled using the concepts of clinical pharmacology. Learning Objectives: How the PK/PD principles are applied to the ADC modality Clinical pharmacology considerations of ADCs Application of MIDD concepts for ADCs Speaker Information Eshita Khera, Novartis Claire Li, Daiichi Sankyo
Lorem ipsum ad aute eu aliquip ea Ut sed esse labore minim nost.
CTA