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By Anke Rosch, Boehringer Ingelheim | Statistics have been showing that rodent and non-rodent experiments predict human toxicity in only 48-71% of drugs. The FDA Modernization Act 2.0 of 2022 permits the use of suitable animal-free new approach methodologies, and the European Parliament launched a program to eliminate animal studies "as soon as scientifically possible." Let's take a data-driven, research-driven look at the topic. |
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4 Strategies To Formulate Poorly Soluble APIs | By Rajendran (Raj) Arunagiri | One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. This article examines four notable strategies. |
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| Key Stages In mRNA-Based Therapeutic Development | White Paper | Precision NanoSystems | Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset. |
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| Effects Of The Ongoing Pandemic On Bupivacaine HCI Supply | White Paper | By Hamid Parsa, Cambrex | Throughout the pandemic, painkiller and sedative demands spiked. Drug manufacturers and CDMOs have become critical in efforts to stabilize the supply of bupivacaine HCl and other essential drugs. |
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| Harness High-Quality PBPK Modeling To Enhance Clinical Readiness | Article | By Deanna Mudie, Ph.D., Lonza, and John DiBella, Simulations Plus | Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties. |
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