Toxicological Insights for the Global Pharmaceutical Industry
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ICH Guidance “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals” issued
The guidance provides recommendations for preclinical studies for the development of pharmaceuticals, including both drugs
and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of preclinical studies to support an investigational
new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA).
New MHRA pharmaceutical directory resource
The UK Health Agency (MHRA) now has a one-stop page for the pharmaceutical industry to access information.
Strengthening the business of personalized medicine
Pharmacy benefit managers (PBM) may be tweaking the business model for personalized medicine, thereby enhancing drug safety. PBMs anticipate to make money by selling personalized medical services to employers, who are willing to pay them higher fees for improved health outcomes and lower prescription costs.
Drug Pharmacokinetic Comparison between Humans and Monkeys
For 8 of 13 drugs, the results suggest that first-pass intestinal metabolism is greater in cynomolgus monkeys than in humans, and that bioavailability in cynomolgus monkeys after oral administration may be unsuitable for predicting pharmacokinetics in humans.
Preclinical Safety Evaluation: moving from risk identification to risk reduction
Revolutionizing the way that toxicology is applied, such as moving from a hazard identification and risk assessment preclinical paradigm to one that reduces or eliminates risk prior to major expenditures, may provide a means of narrowing the productivity gap within the biopharmaceutical industry. This paper provides an overview of safety issues for initial exploration and cites possible techniques available to address them in the preclinical space.
New Regulatory and Enforcement Emphasis of FDA on Drug Safety
James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety.
GI models aid preclinical drug development
Seventh Wave Laboratories now offers a battery of gastrointestinal (GI) preclinical models to help clients to assess the behaviour of oral medications.
FDA Transparency Initiative
The FDA launched a web-based resource called “FDA Basics” that provides basic information about the Agency and how it does its work.
Evolving FDA and EMEA Collaborations
Distillation of an interview with Murray Lumpkin, who is spearheading the FDA’s efforts to collaborate with the EMEA, discussed the history and context of the collaboration and drug safety (preclinical and clinical) initiatives, among others.
Drug Safety Emphasis Did Not Slow FDA Drug Approvals in 2009
New drugs cleared by the FDA in 2009 kept pace with 2008 and boxed warnings decreased, suggesting the tougher approach to drug safety has not slowed approvals.
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