Solvi Pharma Consult’s Post

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

Alhamdulillah, I am happy to share that my first research paper entitled "𝐀 𝐫𝐞𝐭𝐫𝐨𝐬𝐩𝐞𝐜𝐭𝐢𝐯𝐞 𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐝𝐚𝐭𝐚 𝐫𝐞𝐠𝐢𝐬𝐭𝐫𝐲 𝐢𝐧 𝐚 𝐭𝐞𝐫𝐭𝐢𝐚𝐫𝐲 𝐭𝐞𝐚𝐜𝐡𝐢𝐧𝐠 𝐡𝐨𝐬𝐩𝐢𝐭𝐚𝐥 𝐢𝐧 𝐉𝐨𝐫𝐝𝐚𝐧" has just been published in the Journal of Pharmaceutical Policy and Practice (#Scopus: Q1; Impact factor: 4.7) Special thanks to my team and supervisors Prof. Khawla abu hamour and Dr. Rund hyari for their continuous efforts and support. Enjoy reading by the following link: https://lnkd.in/gEQmzmVr

Our Biotech Review of the Year is now available!   Are you interested in finding out about 2023 biotech developments and a forecast for what lies ahead in 2024 and beyond? This publication, now in its 11th year, includes articles from a range of different topics written by our specialist life sciences lawyers. Topics include how to integrate generative AI into the life science ecosystem and looking at the Commission’s proposals to reform the EU pharmaceutical legislation.   Read in full here: https://lnkd.in/dMb2-Px6

Very proud to have contributed to Bristows LLP’s Biotech Review of the Year - which is just hot off the press! 😀 Check it out via the link below. Many thanks to my co-author Erik Müürsepp for his thoughts in our article on CDMO contracting arrangements for cell and gene therapies. Above all, big shout out to everyone else who worked on this year’s publication which covers so many interesting and diverse topics affecting the life sciences sector today. Easy to dip in and out of - there’s something in there for everyone working in or with the industry. #lifesciences #biotech #celltherapy #cellandgenetherapy

It was great meeting bright minds from Biotech/Pharma at #BiotechTuesday event and discussing Drug Development pathway! The insights received from the leaders in the Industry are always impressive! #drugdevelopment #cmc #preformulation #formulation #manufacturing #drugsubstance #drugproduct #research

FDA just published a draft Guidance for Industry on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies providing recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biologic license applications (BLAs). In a nutshell it refers primarily to the ALCOA principle, however reference is made to recent inspection findings: therefore, worth reviewing!

How do you ensure that pharma campaigns are based on evidence rather than assumption? Through methodology, framework and structure. After a series of failed launches, a more involved approach will be required for drugs that treat Alzheimer’s, Parkinson’s and other neurodegenerative diseases. That’s where behavioural science comes in. You can read about how behavioural science has been used successfully in this article for the International Pharmaceutical Industry Journal by William H: https://lnkd.in/emfAKUSj

🚀 Excited to have participated in the 41st SPSR Webinar on "Intelligent Drug Delivery System: Futuristic approach towards translation and personalized medicine" organized by Society of Pharmaceutical Sciences and Research (SPSR) on the occasion of National Science Day, February 25, 2024. The webinar was a thought-provoking discussion on the advancements in drug delivery systems and how it can revolutionize the field of medicine. The speakers shared their insights on the potential of personalized medicine and how it can improve patient outcomes..!! #SPSRWebinar #IntelligentDrugDelivery #PersonalizedMedicine #FuturisticApproach #NationalScienceDay🧬 #DrugDelivery #FutureOfMedicine

#Bioequivalence_study part2 “Generic medicines” In applications for generic medicinal products, the concept of bioequivalence is fundamental. The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with reference medicinal product. A generic medicinal products is a product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers,complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. #bioequivalence #genericmedicines #genericdrugs

🚀 Thrilled to share that my latest chapter, *"An Overview of Acid Sphingomyelinase Deficiency: "A Clinical and Immunological Perspective"* is now part of the esteemed book *"Research and Reviews in Pharmaceutical and Health Sciences Volume II"!* 📘✨ Can't wait to dive into discussions and share insights with you all!