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The new approach to develop quality in pharmaceuticals is by implementing Quality by Design (QbD). It explains the use of Quality by Design to guarantee pharmaceutical quality. In this review, the QbD is described and some of its components are specified. Even though the Quality can be checked on products, integrating within the design will be more effective. The quality by design is based on the ICH guidelines and USP also requires compendial product consistency evaluation checks on the market. As far as industry is concern - it is improving the quality and safety of their products by application of DoE using various software, since the cost of each software is higher, choosing the best software which has easy user interface as well as more performance is concerned. These QbD is implemented with creating DoE in the statistical application of production data with the help of various commercially available software (JMP®, MODDE®, MINITAB®, STATISTICA®, etc.,). The potential power of each software is unique and their functionalities are reviewed in this article. And it also gives you a brief idea about the software towards advancement in pharmaceutical sector in term of quality and safety. [ABSTRACT FROM AUTHOR]

Nanotechnology is a multidisciplinary d0omain which has provoked a significant impact on clinical medicine. Throughout the years nanotechnology has evolved in various aspects rendering multiple applications in the field of pharmaceutical development and overcoming the problems of conventional techniques. Nanotechnology has already acquainted with oncology facilitating the treatment of tumours. Nanotechnology posses various characteristics like preferential accumulation of chemotherapeutics in tumour, low distribution in normal tissues, pharmacokinetics, biodistribution and clearanceproviding improved diagnosis and tumour treatment. Though the field of oncology developed massively, limitations still exists in treating neuronal tumours due to intricate structure of the blood-brain barrier. Nanotechnology with its feasibility to attachvarious molecules on their surface and transform them into excellent transport vehicles with ability to cross cell and/or tissue barriers, including the BBB. This review elaborately delivers the techniques and strategies used to improve the diagnosis and to treat neuronal tumours unlike conventional cancer therapies. [ABSTRACT FROM AUTHOR]

Personalized medicine is a clinical model that isolates individuals into various groups with clinical choices, practices, intercessions and additionally items being customized to the individual patient dependent on their anticipated reaction or danger of disease. The utilization of genetic data has assumed a significant part in personalized medicine (e g pharmacogenomics). Modern advances in personalized medicine depend on innovation that affirms a patient's major DNA, RNA, biology or protein, which at last prompts confirming disease. The ideas of personalized medication can be applied to new and extraordinary ways to deal with medical services. The history of personalized medicine is clearly discussed in this article. And with that, literature review on various type of clinical trial was done. The two types of clinical trials are conventional clinical trial and differential clinical trial. The conventional clinical trial is a regular trial in which simple drugs are evaluated and the study can be done by observing all the phases. But in the case of differential clinical trial, the clinical trial is been carried out on complicated diseases and personalized medicines, where there are no proper regulatory guidelines to be followed. It is concluded that the advancing field of personalized medication is an emerging zone with a range of applications for rare diseases, which include actual advances in clinical trial outcomes for properly chosen patient sub-sets. [ABSTRACT FROM AUTHOR]

At present, In the pharmaceutical industry, the quality by design approach is widely used to obtain products with reliability and efficacy. Quality by design allows us to understand both product and process control through clear research and quality risk management. As QbD helps in building quality in all pharmaceutical products, it widely practised. But it may also be a drawback for few industries in which processes are fixed in time. It is one of the growing area which helps maintaining high quality standards and real time release of the drug product. To deliver a product performing its intended action by maintaining its quality, is the prime aim of pharmaceutical development. Implementation of QbD is widely encouraged by Food and Drug Administration (FDA) and International Conference on Harmonization (ICH). This study explored the pharmaceutical QbD and discusses how it can be used within the specified time frame to produce pharmaceutical products efficiently. In this review, a brief overview about QbD and its elements such as quality target product profile (QTPP) critical quality attributes (CQAs), Quality Risk management (QRM), Control strategy and continual improvement will be discussed. Moreover, an overview about water as a QbD element was also discussed. Understanding the concepts of QbD is essential as most of the pharmaceutical industry are moving towards implementing QbD in their area. So, QbD will act as a bridge between drug application review and risk-based drug development. [ABSTRACT FROM AUTHOR]

Post market examination is to safeguard end users through the close watch of IVDs offered for sale or distribution in the country. Through this action product owner must aware of the problems arises with the IVD in use and analysis the risk associated with the problem reported and take appropriate action to avoid repetition and ensure quality of the IVDs in the market. Rigorous pre-market assessment of IVDs is done by the regulatory authorities; however, there is no enough system and guidance in place for the monitoring of the post-marketing phase of IVDs in most countries including India. This article has been prepared to facilitate and strengthen the reporting of Events attributable to in-vitro diagnostic medical devices in India, harmonized with WHO, National and International best practices. This article suggested the various stakeholders follow this guidance involved in the post market phase of IVDs relates to monitoring of adverse events, reporting of adverse events, reporting timeline, examination of the complaint to determine source, and the subsequent suitable action. This article also aims to create awareness among users about the importance of reporting adverse events relating to the IVDs in India. In order to monitor the quality of the IVDs available in the country and encourage the reporting, this article also urges the central government to make online portal under respective authorities for mandatory reporting, report suspected counterfeit IVDs, for voluntary reporting serious adverse event, product quality problem, product use/medication error, or/failure that is associated with the use of an IVDs. [ABSTRACT FROM AUTHOR]

Personalized medicine, which is both encouraging and exciting that a new effort is underway to create tailormade medicine and medical treatments by drawing on exceptionally detailed and extensive biomedical data. Each patient is unique; hence "one size fits all" is not effective which are currently used in HealthCare. Here these are the tailoring of medicine in which dosage forms can be formulated in a challenging basis, based on the Genomic information of the patients which may lead to a success rate of completely curing the disease. Personalized medicine also helps to diagnose patients in a highly specific manner, allowing more effective and targeted therapy. Formulation opportunities are more for these approaches, which already exist in a market particularly 3D Printing of Tablet, mini pills, film dosage forms and also in immunotherapy. Though it having more advantages, it faces more challenges as we are already in a Prescribing medication using "Trial & Error method" which was preferred by long period of time; and numerous issues which have started to arise, including legal (intellectual property rights and Regulatory frameworks), Ethical and Social issues (Confidentiality and Privacy of Patients). Patient privacy, if patient's genetic data was leaked, many issues may be presented. For example, inappropriate use of this information by insurance companies, who may not offer policies to certain individuals with genetic diseases. As all the industries presently targeting prescribing medicine, because of personalized medicine the excipient grade may have to change because of Technologies involved, such as 3D printing, and it may lead to change in formulation strategy. In other hand, Scientific and Technological advances in the genomics field mean that cost and time are no longer a barrier for precision medicine. Moreover personalized medicine, the effort is ambitious, challenging and possible. [ABSTRACT FROM AUTHOR]

Capsules are the unit solid dosage forms in which the drug can be incorporated into the shell. Gelatin is the major polymer used for capsule preparation which is natural polymer obtained from animal source i.e. skin and bones of pigs and cows. The usage of gelatin in capsule making is decreased due to many reasons like source of gelatin is from animals which causes mad cow disease and cross linking of gelatin with drugs which decreases the efficiency of drug. Because of this reason, development of capsule shell using various raw materials is necessary to replace the gelatin. Moreover this review helps the capsule manufacturer to prepare the capsule shell using other synthetic and natural polymer. [ABSTRACT FROM AUTHOR]