Efficacyand safety of a new herbal cream containing aqueous extracts of Azadirachta indica, Curcuma longa, Pongamia glabra, Glycyrrihiza glabra and Santallum album were evaluated in amulticentric, randomized, double-blind, placebo-controlled study. With active drug treatment, there was significant improvement in various signs like redness, oedema and symptoms like itching, burning, discharge an...

The guidance for safety testing of drug metabolites ¤MIST¥ from the FDA ¤2008¥1¥ and the ICH ¤2009¥2¥ has had significant impact on drug discovery and development. Before the MIST guidance, there were no regulations for drug metabolites. Nonclinical evaluation of drug safety is assessed by comparison between systemic exposure in nonclinical studies and in human studies; therefore, the nonclinic...

INTRODUCTION From a drug discovery point of view, ion channels are very interesting and challenging targets. Over the past decade, great efforts have been made in developing platforms for patch clamp-based high-quality screening of ion channels in discovering new drug candidates as well for evaluating their safety profiles. Indeed, the automated patch clamp (APC) has recently reached the data t...

Discussed in this Brief: The National Evaluation of Operation Weed and Seed, a strategy to control violent crime, drug trafficking, and drug-related crime in targeted areas and to provide a safe environment for residents to live, work, and raise their families. From the initial three grant sites in 1991, Weed and Seed has grown to include 200 sites nationwide. The Weed and Seed programs in eigh...

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles wi...

Drug-induced liver injury (DILI) is a significant concern in drug development due to the poor concordance between preclinical and clinical findings of liver toxicity. We hypothesized that the DILI types (hepatotoxic side effects) seen in the clinic can be translated into the development of predictive in silico models for use in the drug discovery phase. We identified 13 hepatotoxic side effects...

In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER...

Our American system of drug regulation is heavily frontloaded. The FDA spends a lot of time and energy (though not always enough) evaluating a proposed drug's safety and efficacy before approving it. But this initial evaluation is inherently constrained by the limited data available from clinical trials conducted before the product enters the marketplace. Ultimately, the FDA makes a judgment ba...

1 Ji Hyung Park, 1, 2 Dae Gon Woo, 1 Dae Woon Lee, 1 Chi Hoon Kim, 3 Beob Yi Lee and 1* Han Sung Kim 1 Department of Biomedical Engineering and Institute of Medical Engineering, Yonsei University, Wonju, Korea 2 Medical devices Research Division, National Institute of Food and Drug Safety Evaluation, Korea Food & Drug Administration, Seoul, Korea 3 Department of Anatomy, School of Medicine, Kon...