🔔Coming October 9: SBIA Webinar on ICH M12 Drug-Drug Interaction Studies Final Guidance If your work relates to drug interactions, drug metabolism, pharmacokinetics, or clinical pharmacology, join us for this webinar which will discuss the full scope of the guidance, which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. Register early! ➡ https://lnkd.in/e6ygc4HH

📣 Today! Earn 2.0 CE hours October 9 with SBIA webinar: ICH M12 Drug-Drug Interaction Studies Final Guidance If your work relates to drug interactions, drug metabolism, pharmacokinetics, or clinical pharmacology, join us for this webinar which will discuss the full scope of the guidance, which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. Log in early! ➡ https://lnkd.in/e6ygc4HH

Engaged in early oligonucleotide development? If yes, you should take note of this new FDA guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. In detail the guidance refers to the following clinical pharmacology topics: (1) characterizing the potential for QTc interval prolongation, (2) performing immunogenicity risk assessment, (3) characterizing the impact of hepatic and renal impairment, and (4) assessing the potential for drug-drug interactions. A series of oligonucleotides have been approved during the last years (fomivirsen, mipomersen, eteplirsen, nusinersen, inotersen, patisiran, givosiran, golodirsen, and vitolarsen), and the recent FDA guidance translates the experience with the approval of these drugs into this new Guidance for Industry. In this context reference is made also to a review paper published by Rogers et al in 2021 (Clin Transl Sci (2021) 14, 468–475; doi:10.1111/cts.12945) #oligonucleotide, #EarlyPhase, #ClinicalPharmacology

Clinical Pharmacology in Drug Development (CPDD) is an international, peer-reviewed, online publication of the ACCP focused on publishing high-quality clinical pharmacology studies in drug development. https://bit.ly/39XjxMS

The FDA finalized guidance on how sponsors can design clinical pharmacology studies to support the safety and efficacy of ADCs. Find out how the final guidance differs from the draft version issued in February 2022 here: https://bit.ly/3T1hqgi #Clinicalpharmacology #FDAGuidance #ADCs

There's plenty of confusion when it comes to designing clinical pharmacology studies to support filing packages and labeling. In a new webinar, Dr. Neha Bhise, Associate Director of Clinical Pharmacology at Allucent, takes you through the significance of clinical pharmacology in overall drug development and the key clinical pharmacology studies that are critical to inform drug labeling and filing packages. Dr. Bhise also walks through several impactful case studies to illustrate how drug developers supported dosing recommendations in drug labeling. Watch the webinar here: https://lnkd.in/dtyqtXhu #Allucent #BringNewTherapiesToLight #DrugDiscovery #Pharmacology

The FDA has released a final guidance on clinical pharmacology for antibody-drug conjugates with a cytotoxic small-molecule drug or payload. Some of the considerations and recommendations addressed include: • bioanalytical methods • dose- and exposure-response analysis • intrinsic factors  • QTc assessments • immunogenicity • drug-drug interactions (DDIs) Read the full industry guidance below. #FDA #DrugDevelopment #bioanalysis

Two weeks today Altasciences will be hosting the symposium 'Current Trends for Efficient Drug Development' on Campus. Speakers include Robert Wilson, Drug Development and Clinical Pharmacology Director, at Healx who will share details of incorporating AI in drug discovery. Other topics will include regulatory pathways to conduct first-In-human trials in Canada and the journey of an obesity compound that has been 20 years in the making. Registration is essential - https://ow.ly/P69f50RFGlt

🔔 Join us October 9 for SBIA webinar: ICH M12 Drug-Drug Interaction Studies Final Guidance If your work relates to drug interactions, drug metabolism, pharmacokinetics, or clinical pharmacology, join us for this webinar which will discuss the full scope of the guidance, which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. Have you registered yet? ➡ https://lnkd.in/e6ygc4HH

🔔 Join us October 9 for SBIA webinar: ICH M12 Drug-Drug Interaction Studies Final Guidance If your work relates to drug interactions, drug metabolism, pharmacokinetics, or clinical pharmacology, join us for this webinar which will discuss the full scope of the guidance, which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. Have you registered yet? ➡ https://lnkd.in/e6ygc4HH