WuXi Chemistry’s Post

The first version of USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas became official, and it is the fourth part of USP General Chapter <1079> on Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, which also includes: - USP General Chapter <1079.1> on Storage and Transportation of Investigational Drug Products - USP General Chapter <1079.2> on Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Product - USP General Chapter <1079.3> on Monitoring Devices – Time, Temperature, and Humidity

Great to see the Center for Research on Complex Generics (CRCG) and FDA team up again to discuss another important topic! #Complexgenerics

The conference report about EUFEPS open forum on ICH M13A is now available! During the meeting the most relevant aspects of the ICH M13A draft have been discussed in order to contribute scientifically to the decision process of guideline finalisation. Major aspects have been the choice of study population (females and/or males), request for fasted and/or fed studies, consequences of differences in drug product content, handling of aberrant plasma profiles and additional requirements in case of pH-dependant solubility. We are happy that Ralph-Steven Wedemeyer, our expert on biopharmaceutics, contributed to the program, the conference as well as to the report as one of the co-authors. #Bioequivalence #EarlyPhase #Biopharmaceutics https://lnkd.in/eg8mJe_G

The FIP biowaiver monographs contain a comprehensive summary of literature data relevant to the application of biowaivers based on the Biopharmaceutics Classification System (BCS). These monographs are compiled for all drug substances that are included on the WHO Model List of Essential Medicines. A free virtual issue with previously published biowaiver monographs is now available. This includes one of our contributions to the biowaiver monographs series containing the relevant literature data pertaining to the anthelminthic drug levamisole. The issue contains a wealth of data and is especially of interest when you are working on related topics. Find the virtual issue here: https://lnkd.in/ePpmfwAb Find the Levamisole biowaiver monograph here: https://lnkd.in/e7RsKdp8

𝐀𝐭𝐭𝐞𝐧𝐭𝐢𝐨𝐧 𝐆𝐞𝐧𝐞𝐫𝐢𝐜 𝐃𝐫𝐮𝐠 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐞𝐫𝐬! 💊 𝐃𝐞𝐞𝐩 𝐃𝐢𝐯𝐞 𝐢𝐧𝐭𝐨 𝐅𝐃𝐀'𝐬 𝐌𝐈𝐄 𝐏𝐢𝐥𝐨𝐭 𝐏𝐫𝐨𝐠𝐫𝐚𝐦: 𝐀 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐘𝐨𝐮 𝐂𝐚𝐧'𝐭 𝐌𝐢𝐬𝐬! 📅 Mark your calendars for January 18, 2024 for a crucial webinar on the FDA's Model-Integrated Evidence (MIE) Industry Meeting Pilot Program. Why attend? 1️⃣ Get firsthand insights from FDA experts on navigating the MIE pilot program for bioequivalence (BE) establishment in generic drug applications (ANDAs).  2️⃣ Discover best practices for implementing MIE and address complex scientific and regulatory challenges.  3️⃣ Learn the types of topics covered under the pilot program and maximize your chances of a successful meeting. Don't miss this opportunity to gain valuable knowledge and stay ahead of the curve in the generic drug landscape. 🔗 Register now: https://lnkd.in/dJRmDF5g Share this post with your network! Let's spread the word about this vital resource for the generic drug industry. FDA #FDA #MIE #GenericDrugs #Bioequivalence #Webinar #DrugDevelopment CDER Small Business and Industry Assistance (SBIA) #ModelingAndSimulation P.S. Check out the event page for more information and FDA resources: https://lnkd.in/dwiEY3G3. Let us know if you have any questions! InSilicoMinds is here to help you make the most of this exciting opportunity.

Egypt FDA published the Draft document mainly provides information regarding nonclinical and early clinical studies 80 of liposomal drug products and nano-similar liposomal drug products from regulatory point 81 of view by identifying the points to be considered in the development of liposome drug 82 products. 83 Liposome drug products described in this document are also subject to other relevant 84 notifications and guidelines. The active substances mentioned here include a low-molecular- 85 weight chemical entity, a nucleic acid or a biological or biotechnological entity, including, 86 for example, peptides and proteins. #regulatoryaffairs #egyptFDA #regulatory #regulation #regulatorysubmission

Egypt FDA published the Draft document mainly provides information regarding nonclinical and early clinical studies of liposomal drug products and nano-similar liposomal drug products from regulatory point of view by identifying the points to be considered in the development of liposome drug products. Liposome drug products described in this document are also subject to other relevant notifications and guidelines. The active substances mentioned here include a low-molecular weight chemical entity, a nucleic acid or a biological or biotechnological entity, including, for example, peptides and proteins. #regulatoryaffairs #egyptFDA #regulatorysubmission

Join me and a panel of FDA subject matter experts next Thursday afternoon, 1-4 pm EDT. Learn more about product-specific guidances (PSGs) in this webinar! Hear from FDA experts on updates and insights to help your generic drug development programs. #generics, #PSG

Delve into a discussion with experts from FDA and industry about MIDD Strategies in RNA-Based Oligonucleotide Drug Development in this upcoming #ASCPTwebinar. 4/24 at 12 pm ET: https://bit.ly/49MdUxw

PSGs describe the Agency’s current thinking and expectations on how to develop generic drug products that are therapeuticly equivalent to RLDs. Join us in this webinar to learn how they are developed, revised, and published so that you can use them to improve efficiency in generic drug development.