{"id":7693,"date":"2024-06-20T11:42:06","date_gmt":"2024-06-20T16:42:06","guid":{"rendered":"https:\/\/labtesting.\/?p=7693"},"modified":"2024-06-20T11:42:10","modified_gmt":"2024-06-20T16:42:10","slug":"the-vital-role-of-toxicity-studies-in-new-drug-development","status":"publish","type":"post","link":"https:\/\/labtesting.\/2024\/06\/20\/the-vital-role-of-toxicity-studies-in-new-drug-development\/","title":{"rendered":"The Vital Role of Toxicity Studies in New Drug Development"},"content":{"rendered":"\n
Toxicity studies are vital to the drug discovery process. Through rigorous testing, researchers compile all the necessary data to understand a new drug’s safety profile and advance it toward patient use.<\/p>\n\n\n\n
Before drugs are approved for clinical testing, researchers utilize several safety studies to establish precisely how toxic the product is at various doses and over different time periods. These studies monitor the overall response to a drug, any adverse reactions in target organs, dose dependence, and sometimes potential reversibility. <\/p>\n\n\n\n
Data from safety studies is used to determine the safe starting dosage for clinical trials. Once trials in humans begin, the information is also used to establish the parameters needed to monitor for any potential side effects. <\/p>\n\n\n\n
If any serious adverse events occur during clinical or nonclinical trials, studies can be discontinued, and close scrutiny will be placed on whether the study design was correct and whether the compound was proven safe enough for further testing. Efficient and comprehensive toxicology studies form the bedrock of any drug\u2019s regulatory approval, and they\u2019re only getting more critical as our understanding of drug interactions and human biology becomes more complex.<\/p>\n\n\n\n
There are many types of toxicity studies. If regulators are to green-light human trials, these must be completed in preclinical testing. They include: <\/p>\n\n\n\n
Other types of toxicity testing must also be completed, including toxicokinetic and pharmacokinetic. Carcinogenicity studies focus on whether the drug candidate has the potential to cause cancer, genotoxicity studies evaluate whether the drug can cause genetic mutations, and reproductive and developmental toxicity studies focus on potential harm to the reproductive and developmental functions of the human body. <\/p>\n\n\n\n
Toxicity testing remains a crucial element in drug development, and future advancements in technology promise to simplify the task and improve results. Traditionally, toxicity studies have relied heavily on animal testing, but significant changes are on the horizon, aligned with the three Rs approach: replace, reduce, and refine, which is gaining support worldwide.<\/p>\n\n\n\n
Increased computing power is set to revolutionize toxicity testing. Enhanced computational models can make more accurate predictions regarding toxicity, thereby speeding up the testing process. Additionally, high-throughput screening techniques are improving in vitro <\/em>testing, allowing for the rapid assessment of numerous compounds simultaneously.<\/p>\n\n\n\n These advancements hold the promise of more efficient, ethical, and accurate toxicity testing, ultimately accelerating the drug development process and bringing safer pharmaceuticals to market faster.<\/p>\n\n\n\n Toxicity studies are a crucial hurdle any developer must overcome to make it to clinical trials. Any inefficiencies at this stage can cost manufacturers time and money, and if they go unnoticed, they can even cost lives. As medicine advances at an increasingly rapid rate and personalized medicine, AI-enabled drug discovery, and other elements become increasingly important, the role of toxicity studies will become even more paramount. Manufacturers need to conduct thorough and efficient toxicity studies. They would do well to find a trusted and experienced lab partner if they lack in-house resources and expertise to perform these critical studies.<\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n\n\n\n As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec\u2019s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the third consecutive year in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need \u2013 and to realize the vision that “every drug can be made and every disease can be treated.\u201d<\/em><\/p>\n","protected":false},"excerpt":{"rendered":" Toxicity studies are vital to the drug discovery process. Through rigorous testing, researchers compile all the necessary data to understand a new drug’s safety profile and advance it toward patient use.<\/p>\n","protected":false},"author":16,"featured_media":7694,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","content-type":"","footnotes":""},"categories":[8,40,11],"tags":[37],"yoast_head":"\nA final word\u00a0<\/h2>\n\n\n\n
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