Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 6, Issue 2, 2019

Background: Probiotics is a broad term used for friendly bacteria which are increasingly used in present scenario due to their wide range of health benefits accompanied by low cost and negligible side effects. The status of the probiotics as a component of food is not clear in the health industry. The use of probiotic bacteria is exploited over-the-counter as dietary supplements or in food products such as yogurt, as well as in the pharmaceutical preparations too. These products have witnessed tremendous growth in the market around the globe. For acceptance of probiotics based products with uniform quality, greater safety of patients, with established scientific evidences for holistic therapeutic benefits in the treatment of various ailments, appropriate drafting and implementation of comprehensive regulatory guidelines is the need of the hour. So in this context, already prescribed guidelines in India are reviewed critically. Conclusion: This article has been compiled to highlight the variations of food safety standards since 2002 to till date along with the existing ambiguities. Moreover, suggestive consolidations are compiled to take a lead for framing a comprehensive and harmonized guideline to be accepted universally.

Background: Pharmaceutical excipients are critical in the formulation of any dosage form. Not many additives employed in the drug product manufacture have properties, which meet the desired qualities that the finished product must have. Therefore, it is mandatory to mix the drug substance with other substances to overcome the deficiencies. As a result, almost all pharmaceutical products are mixtures of active pharmaceutical ingredient and additives. So, there is a compelling need of these substances and normally they occupy the major part of any drug product. Excipients are of different chemical categories that have varying physicochemical properties like solubility, miscibility and the nature and source of these materials vary. With growing number of pharmaceutical excipients and polymers, the question of evaluating their toxicity is becoming a complex issue. Many polymers and novel excipients are now available in the market and with their diverse chemical nature and different sources and presence of impurities and their adverse effects will further complicate the safety profiling of these excipients. Conclusion: This review article will discuss the unwanted biological activities of some commonly used excipients and issues of the supply of the pharmaceutical excipients that need to be highly regulated and monitored to ensure availability of quality and pure excipient compounds.

Background: In pharmaceutical terms, quality means a product free from any contamination and delivers the therapeutic benefit specified in the label at a reproducible rate which can be assessed by carrying out in vivo or in vitro tests for evaluation of performance. Quality by Design (QbD) is a necessary tool in pharmaceutical environment for having product/process/method impregnated with quality. QbD is a move toward drug development that ensures the preplanned product specifications by providing guidance for architecting the manufacturing processes and formulation. Methodology: It has provided the solution to support both the regulatory bodies and industry to shift towards added proactive and scientific approach. QbD is the greatest solution to construct quality in all pharmaceutical products, while at the same time, making it a part of the system is also a key challenge for the industry. By using QbD concept, regulators as well as industries are making a move in geometric progress in bringing quality products. Regulatory bodies across the world are showing significant attention to QbD. Conclusion: Therefore, an attempt has been made to highlight quality by designing generic drugs and its implications to pharmaceutical industry including clinical trials, pharmaceutical validation processes and in biologics and also to provide a brief description on the status of QbD in India and as well as in Asia.

Introduction: Many physicians may be unfamiliar with the importance of hyaluronic acid (HA) and its physiological and biochemical functions at cellular level. Despite the vast number of published studies using HA in medical treatments, it is still difficult for the reader to clearly distinguish the different types of HA employed in different medical applications. In addition, published studies do not mention the exact type of HA used or its biochemical properties. Usually, a study mentions only its molecular weight and concentration, which are insufficient to know its exact designed properties or to make a comparison with other types of HA. Methodology: This article is intended to summarise the information about native and modified HAs with a focus on explaining their different physiological and biochemical functions in the human body, their different commercially available types, and how they affect the associated medical applications. The goal is to provide a basis to researchers and physicians for distinguishing different types of HA and their properties in order to enhance physicians’ clinical practice in terms of application of different types of HA to treatments and to help the international research community to change the reporting of HA characteristics in published papers. This is necessary to enhance future acquisition of data, with the ability to create an HA data bank for further research and as a reference for different HA types and their medical applications. Conclusion: These developments should enhance the scientific and clinical knowledge about HA. Furthermore, the overall approach in this paper can be applied to other similar substances.