Preclinical Research: A Rise or Dawn

Abstract

IntroductionComplex processes are involved in developing a new drug along with its time and costs consumption. Prior to launching, it requires variety of evidences to show its potential activity [1]. Key step in drug discovery is considered to be the target discovery which ranges from molecular entities to biological phenomenon [2]. As there are urges in translating scientific discoveries into practical importance, preclinical studies using animal models play an important role in evaluating the efficacy and safety under clinical scenario [3]. After enormous debates, it is concluded that the benefits of animal research is worth to manage public health and medical research [4]. Subsequently, animal studies are justifiable if done in a way to minimize pain in animal models and wherever applicable alternative methods are explored and avoiding unnecessary cruel treatment to animals [5]. However, various reports have enforced on the failures of trails that has never capitalized after thorough observation of safety and efficacy in animal models which mainly portraits the requirement of robustness in preclinical studies [6][7][8][9][10]. For instance, reports say that, almost 95% of drugs that enter clinical trials related to stroke or septic shock do not get launched in the market though enormous expenditures have been dealt with the basic studies and drug discoveries [11] and similarly, the average success rate in clinical cancer trials is less than 8% after preclinical estimation [10].Still it is recommended to circumvent preclinical studies because of the scientific, practical and ethical reasons, to conduct studies in humans [6], and thus prior to this attempt, preclinical drug combination studies in vitro and/or in animals has to be carried out to obtain the base for studies in human [12]. Though the debate over use of the animals in medical experiments has a long and unpleasant history, eminent researches along with Nobel Prize winners have signed a declaration provided by the Research Defense Society has made claim that experiments on animals have made important contribution to advances in medicine and surgery [13]. Research focused on pain research has shown enormous rate of failures and increased costs of drug development this is because of phenotypic differences and complexity in behavioral alterations along with the changes in daily activities and psychological disturbances [14,15]. Moreover, the test and models of nociception has been questioned in the aspect of appropriateness between tests, models and procedures [16]. Thus in order to develop robustness in pain management and to effectively gather required evidences, it is better to evaluate pain states in higher order preclinical species where we can predict whether biological mechanisms and specific compounds have relevance for clinical pain better than rodent species. The pain models in non-rodent species may enhance the speed, and in addition reduce costs along with the increased probable results for a successful analgesic development [17]. Hiccups in...

histopatología: una herramienta imprescindible en el estudio de moléculas antioxidantes con actividad terapéutica.

“…Estos últimos comprenden estudios de toxicidad aguda y crónica en animales, estudios in vitro de genotoxicidad, toxicidad sobre la reproducción, carcinogenicidad y análisis de riesgos para el medio ambiente o ecotoxidad. (27,28) A partir de los diferentes estudios bioquímicos que se realizan para esclarecer o dilucidar el mecanismo de acción de la molécula en estudio es posible obtener un acercamiento a su posible efecto terapéutico. (25) En las investigaciones dirigidas a moléculas con acción antioxidante, capaces de evitar o revertir los daños tisulares provocados por la POL, los efectos protectores reales sólo pueden ser constatados por estudios histológicos.…”