Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 5, Issue 2, 2018

Advances in nanotechnology are being applied in the development of novel therapeutics that may address several shortcomings of conventional small molecule drugs and may facilitate the realization of personalized medicine. Interestingly, nanoparticle drug candidates often represent multiplexed formulations (e.g. drug, targeting moiety, and nanoparticle scaffold material). By tailoring the chemistry and identity of variable nanoparticle constituents, it is possible to achieve targeted delivery, decreased side effects, and prepare formulations of unstable (e.g. siRNA) and/or highly toxic drugs. With these benefits arise new challenges in all aspects of regulated drug development and testing. In this review, we provide an up to date snapshot of silver nanomedicines either currently approved by the FDA or other regulatory bodies.

Delivering authentic healthcare Innovation worldwide is a demanding and complex task. The global discovery and approval of new drugs, medical devices and biologics will revolutionize the availability of health care products worldwide. The mission of pharmaceutical research companies is to discover and develop new drugs with safe and effective treatment to patients. Drug development is a science-driven process that at its base involves exploiting biological processes to trigger a therapeutic benefit. The process of discovering and developing a new molecular entity on average requires approximately 13.5-15 years. The developer must reveal efficacy and safety for a novel new drug to become commercially available. A drug in human subjects is governed by rules that fall under the responsibility of overseeing the US Food and Drug Administration. The average cost for the research and development of each successful drug is estimated at $ 800 million to $ 1 billion. The discovery process includes the first steps of the investigation, which are designed to identify a drug in the research and perform initial tests in the laboratory. In this article, we focused on the drug discovery, development process and list of new drugs approved by U.S. Food and Drug Administration (FDA) in 2017.

Background: There has been a phenomenal rise in the nanomaterial-based cosmetic formulations in the market, raising serious concerns over the possible biological impact on humans, animals and the environment as a whole. However, scarce reports can be found on the safety assessment of nanomaterials incorporated in cosmetic formulations including sunscreens. Hence, uncertainties loom for their safe use in cosmetics including those applied dermatologically. Unfortunately, not much research has been devoted to assess the safety profile of nanomaterials in cosmetics and the possible health hazards. As a large number of nanotechnological sunscreen products containing diverse sun filters against UV exposure are penetrating the market, the importance of adequate assessment of nanomaterial exposure, its toxicokinetics including biodistribution, and other health risks is now widely recognized. Objective: The write up presents an overview of the nanomaterials used in sunscreen products and discusses the various laws and regulations in force in various countries. The review focuses on the current safety and regulation of nanomaterials in sunscreens. Conclusion: While many countries have their own set of regulatory guidelines, it is high time to have a globally acceptable guideline framework to protect both the consumers and manufacturers for safe use, manufacture and sale of nanotechnology-based cosmetics. Harmonization across the globe is desirable.

Background: Nanotechnology has found manifold applications in both medicine and cosmetics. It has lead to various beauty solutions by innovating products with nanoparticles or nanocolloidal carriers that can go deeper below the skin surface to give better results. This technology has been used in skin care formulations like sunscreens, antiaging creams, etc. Many natural sunscreen agents (Retinol and Vitamin E) and physical sunscreens (Titanium dioxide and Zinc oxide) have been tried successfully in cosmetics by converting into nanoproducts. Objective: Almost 15000 personal care products and more than 7000 constituents ingredients consists of nanotechnology although, their exposures and potential risks are poorly understood. Various reports of toxicity have lead to concerns for consumer issues like safety, stability, and effectiveness of these products. Various regulatory bodies existing in the world are handling this critical pathway in their own niche. Although issues related to nanotechnology have been addressed but no harmonized status regarding safety, toxicity, and labeling of nanocosmetics is available. Discussion: USFDA has taken an initiative and various committees have been constituted which are involved in deliberations with the manufacturers for making regulatory guidelines for ensuring the safety of the consumers. European Union and Therapeutic Goods Administration have their own perspectives. This article discusses the various regulatory guidelines of nanocosmetics, their applications, issues, and challenges related to consumers.

Background: Nanotechnology has touched almost all the spheres of life and all fields of science globally. It has become a part of everyday routine. Many nanoproducts have already reached the market. Over the last decade extensive research has been done to develop nanomedicines for prevention, diagnosis and treatment of various ailments. The reduced side effects associated with the targeted delivery of nanotherapeutics has increased the focus of researchers in developing drugs for the diagnosis and treatment of many diseases including cancer. Nano-oncology has resulted in successful treatment of topical as well as invasive cancers and has therefore been an area of interest and investment by pharmaceutical industries worldwide. The rapid development of nanopharmaceuticals has created challenges for regulatory agencies, formulators as well as for the academicians. Objective: The present review gives an insight into the different nanoformulations used for treatment of cancers. It also focuses on the regulatory aspects underlying the formulation and use of the nano-onchologicals. Besides this, the safety issues related to their use will also be discussed. Discussion: The extensive formulation of anticancer therapeutics by nanotechnological intervention has been a concern for regulatory agencies worldwide. They have the challenge to frame regulations such that the benefits of these formulations reach the patients but at the same time the safety aspects of these pharmaceuticals are not compromised.

Background: Nanomedicine, defined as the application of nanotechnology for the prevention, cure and diagnosis of diseases, has emerged as one of the most exciting tools in the medical field for direct benefit to human health. Nanomedicine aims to engineer the materials at nanoscale to develop new drugs, delivery systems in a way to mimic or understand the cellular processes at molecular level for therapeutics of diseases. Based on their applications, nanomedicines include nano drug delivery systems, nano-diagnostics, nano-theranostics, and nano-medical implants. Objectives: The current manuscript will provide a global scenario about different nanomedicines and their applications, the overall market, and the ongoing developments in their regulation by different regulatory bodies. Discussion: The different properties displayed by materials at nano-scale in terms of size, chemical reactivity, solubility, mobility, magnetic and optical properties open the ways for their utilization in the field of medicine. The Food and Drug Administration (FDA) has approved products using nanotechnology under different product categories. The last two decades have seen a tremendous growth in the development of nanomedicine-based products in global regulatory markets particularly in the area of drug delivery systems and diagnosis.