Emulate, Inc.’s Post

Streamlining the journey from drug discovery to market is more than a goal—it's a necessity. Our latest white paper explores how 𝗦𝗶𝗺𝗰𝘆𝗽 𝗣𝗕𝗣𝗞 (𝗽𝗵𝘆𝘀𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹𝗹𝘆-𝗯𝗮𝘀𝗲𝗱 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗸𝗶𝗻𝗲𝘁𝗶𝗰) 𝗺𝗼𝗱𝗲𝗹𝗶𝗻𝗴 𝗮𝗻𝗱 𝘀𝗶𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 can enhance drug development efficiency and mitigate potential risks. Click here to learn more: https://ow.ly/htCm50RcnG3 #DrugDevelopment #RegulatorySuccess #DrugApproval #FDA #Pharmacokinetics #PBPK #DDIAssessment #FDAApproval #RegulatoryGuidance #PBPKModeling #DrugLabeling #PharmaceuticalInnovation #DrugInteractions #PharmaIndustry #ClinicalPharmacology #FasterDrugApproval

Revolutionizing Drug Rehabilitation: The Power of Saliva-Based Testing In drug rehabilitation centers, accurate and timely drug testing is crucial for monitoring patient progress and ensuring effective treatment. The EZ Saliva-II offers an ideal solution, providing fast, reliable results with minimal discomfort. Unlike traditional methods, our saliva-based test is non-invasive, easy to administer, and capable of delivering preliminary results and comprehensive toxicology reports from a single sample. With the EZ Saliva-II, rehab centers can streamline their testing process, reducing stress for patients and staff while maintaining the highest standards of accuracy and reliability. It's a game-changer in supporting recovery and enhancing patient care and success. #Rehabilitation #DrugTesting #PCNT #EZSalivaII #HealthcareInnovation #AddictionRecovery #PatientCare #RecoverySupport #InnovativeTesting #RehabCenter

Which is the best weight loss drug? What are the risks? 💉💊 We are witnessing the era of drug therapy for weight loss treatment. In reality pharmacology has been available for over 50 years. There has been a reluctance on the part of doctors to use drug therapy, and a bias within the society at large. This episode expands your knowledge about possible drug treatment options. It also reflects upon the long-term risks of drug treatment, and how to manage pharmacology when target weight has been achieved. The brain defends its weight. Regaining is almost inevitable. Knowing which drugs to use, when to use them, and how to combine them is critical for long-term success. 🎙️ Tune in now! Link in bio. https://vist.ly/3cxxy #WeightLoss #WeightLossJourney #WeightLossTreatment #DrugTherapy #Pharmacology #ObesityTreatment #Healthcare #WeightManagement #LongTermSuccess #PodcastEpisode #intellectualMedicine

The FDA is giving drugmakers and others who are involved in the drug manufacturing process three weeks to comply with new reporting requirements intended to help address potential drug shortages. On 5 February, FDA published a final guidance that details how drug manufacturers and other registrants should submit reports to the agency on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. The requirement is part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act to mitigate future drug shortages. FDA notes that establishments that manufacture drugs in the US must register with the agency. The same applies to foreign establishments that are engaged in making drugs that are then imported into the US. Ferdous Al-Faruque explains in Regulatory Focus: https://bit.ly/493o7W1

𝐅𝐢𝐯𝐞 𝐌𝐨𝐬𝐭 𝐂𝐨𝐦𝐦𝐨𝐧 𝐑𝐞𝐚𝐬𝐨𝐧𝐬 𝐏𝐡𝐚𝐬𝐞 1 𝐃𝐫𝐮𝐠 𝐂𝐚𝐧𝐝𝐢𝐝𝐚𝐭𝐞𝐬 𝐅𝐚𝐢𝐥 🤔 Navigating the path from the laboratory bench to the pharmacy shelf poses a challenge in drug development. Although the likelihood of success increases in later phases, Phase 1 trials represent a crucial juncture where numerous drug candidates may encounter failure. #biotech #drugdiscovery #drugdevelopment #therapeutics

⭐ New for you! The Formulation In-Depth Focus Download to find out more about: 📄 Exploring the complex pathway of paediatric drug development 📄 Definitive screening design to accelerate process characterisation Interested? Download here: https://bit.ly/3Gx8s4G #DrugDevelopment #Formulation

How are you overcoming the challenges of manual-read across? Has assessing the acceptable intake (AI) limits of nitrosamines presented a number of hurdles for your team? ➡️ Diverse chemical structures ➡️ Limited data ➡️ Lack of standardised protocols ➡️ Subjectivity and expert judgement ...Just a number of the challenges faced in the assessment workflow. 💻 In our latest #blog we discuss the complications manual read-across approaches pose, and how this can be mitigated using in silico solutions such as #Acrostic, alongside collaborative data sharing within the pharmaceutical industry. Read our latest blog here: https://buff.ly/4fbVXvo #BlogPost #InSilico #Pharmaceuticals

FDA: 2023 Compliance Trends & Plans for 2024... Officials from the drug, biologics and medtech inspection offices said failure to maintain good manufacturing practices (GMPs) are still among the main reasons for issuing warning letters. “Corrective and Preventive Actions (CAPAs) always remain at the top in the device space [for OAI inspections]. Complaint handling is number two, medical device reporting is third, process validation is fourth, and rounding that out is design changes. There is a large percentage of OAIs that also include unapproved device charges.” For drugs, about 46% of the warning letters were for current good manufacturing practice (CGMP) violations. You can expect FDA to be more active in 2024. How are your GMPs? Are you FDA Ready? We can help. Contact us today to find out how: https://lnkd.in/eFVUfDm #fda #GMP #qualityassurance https://lnkd.in/gqCceZtS

"FDA officials offered insight into their work over the past year and emerging trends at the 2023 enforcement conference hosted by the Food and Drug Law Institute (FDLI). They also discussed plans for the upcoming fiscal year, including cracking down on sponsors who fail to update data on ClinicalTrials.gov, as well as policing manufacturers of counterfeit and contaminated products." #regulatoryaffairs #FDA #biotech #pharmaceutical #productdevelopment #startup #lifesciences #clinical #clinicaldevelopment #preclinical #medicalwriting #CMC #eCTD 

The FDA has recently released guidelines for conducting radiolabeled mass balance studies of investigational drugs in humans. These studies provide valuable insights into a drug’s ADME (absorption, distribution, metabolism, and excretion) within the human body. The guidance addresses key clinical pharmacology aspects, including optimal study timing, design, and result reporting. To know more details on finalized guidance on Radiolabeled Mass Balanced Studies, click the below link 👇 and follow Maven Scientific Laboratories Pvt Ltd for more interesting blogs! https://lnkd.in/gdF9sxsJ #FDA #DrugDevelopment #ClinicalPharmacology #MassBalanceStudies #Pharma #NewDrugApproval #PharmaceuticalResearch #ClinicalTrials #RegulatoryGuidance #DrugSafety #Pharmacokinetics #Biotransformation #DrugMetabolism #InvestigationalDrugs #HealthcareInnovation