Annual teaching event for Dr. Landolfi to Level II Master organized by the University of Bari – Pharmacy University, online thisyear for the Covid-19 pandemic.Annual teaching event for Dr. Landolfi to Level II Master organized by the University of Bari – Pharmacy University, online this year for the Covid-19 pandemic. Cosmetics in the EU […]
25
Dec
Dec
Presented by Dr Landolfi to the online event: Impurity Profiling Live Virtual Conference held on November 26-27, 2020, and organized by CPhl Conferences Topics of her presentation were: Understanding and analyzing guideline and its scope Guideline philosophy and intent Advancements in the guidance – New Appendix Case study Q3D guidance is a quality guideline focused […]
Pubblications
Food toxicity: hazard versus risk – Short Communication in Archives of Clinical Toxicology
05
Oct
Oct
Until recently, eating food has usually been regarded as a low-risk activity. In the last century, industrialization has changed methods and chemicals used in the food supply chain to improve production, maintenance, and acceptance by consumers. Hazardous substances can be used in these processes. However, despite the many potential health risks associated with food, in […]
Pubblications
ICH Q3D: Toxicological Assessment and PDE determination for Elemental Impurities in Topical Drugs
31
Aug
Aug
Elemental impurities (EI) in drug products may arise from several sources. They can be intentionally added or contaminants. EIs do not provide any therapeutic benefit to the patient, therefore, their levels should be controlled within acceptable limits in the drug product (DP). The ICH guideline Q3D(R1) on elemental impurities provides an appropriate process to assess […]
25
Aug
Aug
ICH M7 guideline: beyond synthesis and process-related impurities in pharmaceuticals; applications and perspectives Presented by Dr Landolfi to the online event: 4th Annual Impurities Summit: Genotoxic and Beyond Summit held on September 15-16, 2020, and organized by Vonlanthen. Topics of her presentation are: Extractables & Leachables: M7 approaches in defining limits Cross-contamination: how to deal […]
11
Aug
Aug
PDE DERIVATION FOR CLEANING PROCEDURES ToxHub and our trusted partner Innovatune organize a series of live webinars (free of charge) on: “Chemical and Toxicological Risk Assessment: how to deal with data-poor substances“. Our experts will share their insights on Toxicological Risk Assessment and in silico methods when dealing with chemicals with limited experimental data available […]
11
Aug
Aug
OCCUPATIONAL SAFETY ToxHub and our trusted partner Innovatune organize a series of live webinars (free of charge) on: “Chemical and Toxicological Risk Assessment: how to deal with data-poor substances“. Our experts will share their insights on Toxicological Risk Assessment and in silico methods when dealing with chemicals with limited experimental data available and in different […]
09
Aug
Aug
Any drug treatment may be accompanied by adverse events or toxicity. This is especially true for anticancer therapies, generally named chemotherapies, administered to kill cancer cells. The extent of side effects or toxicity depends on the dose and can vary from subject to subject and from treatment to treatment. It is important to note that […]
06
Aug
Aug
Our Toxicology Expert and CEO, Carla Landolfi, has been invited to give a talk on ICM M7 guideline: beyond synthesis and process-related impurities in pharmaceuticals; application and perspective to the webinar on Genotoxic and Elemental Impurities organized by Volanthen Group. Usually, when we talk about M7 we are talking about a process related substance or […]
Pubblications
Latest update on cytokines and their subset chemokines – Short comunication in Archives of Clinical Toxicology
06
Aug
Aug
Abstract Cytokines and chemokines are engaged in the protection of an organism against external aggressors and diseases. They work together regulating and determining the nature of immune responses and controlling the immune cell trafficking and the cellular arrangement of immune organs. An imbalance or dysregulation in cytokines or chemokines contributes to various diseases where the […]