China
Africa
Explore chapters and articles related to this topic
Anthrax
Published in Meera Chand, John Holton, Case Studies in Infection Control, 2018
The principles of clinical management of cases of cutaneous anthrax are the same as those for any severe necrotizing soft tissue infection: to prevent toxin formation and organism multiplication (antibiotics)to remove the infectious nidus where possible (surgical debridement, usually only in cutaneous disease)to neutralize existing toxin (anthrax immune globulin, anti-anthrax toxin monoclonal antibodies, for example, Raxibacumab)
Drug repurposing strategies and key challenges for COVID-19 management
Published in Journal of Drug Targeting, 2022
Shubham Mule, Ajit Singh, Khaled Greish, Amirhossein Sahebkar, Prashant Kesharwani, Rahul Shukla
Few or more clinical investigations are essential to assess the novel indication unless there is an unusual circumstance like rare conditions like Ebola and anthrax that may be based on preclinical and clinical safety data from healthy volunteers [153]. Anthrasil™, anthrax immune globulin intravenous (human), is an example of this. In 2015, FDA authorised it for the management of people with anthrax infection in conjunction with suitable antibiotic previously approved under the animal rule [153]. When a drug has been in use for not less than 10 years, its safety and efficacy are generally regarded as well-established [153]. In this case, regulatory approval based on scientific literature results may be obtained. When the proposed indication is entirely new, preclinical pharmacological investigations, with the goal of establishing duration and dose of therapy, along with clinical and translational medicine programs may be required, similar to the approval process for a new drug [153]. Decisions on regulatory matters are based on the balance of benefit-risk, and two concerns play a role, in a quickly expanding pandemic: drug approval speed and clinical need urgency. The speed with which therapies are developed to the stage of authorisation is critical in order to keep patients safe from infection as soon as feasible. Other than vaccines, even if a candidate exhibits efficacy in pre-clinical tests, it takes 2–3 years to develop a new chemical entity. Pre-clinical manufacturing operations to verify requisite safety investigations often take around two years before clinical trials can commence. Even though the effectiveness can be shown rapidly, it takes time to assemble a sufficient number of patients to test the new indication, hence establishing the risk factors for small molecules or new biologicals is a difficult task. Regulatory decisions need to be made quickly in some instances, making coordination and communication between national regulatory and health authorities vital. The goal should be to achieve maximum review acceleration without jeopardising the benefit-risk balance evaluation.