1. Introduction Impurity is considered as any component of a drug substance that is not a chemical entity defined as the drug substance and in addition, for a drug product, any component that is not a formulation ingredient [1]. Impurity profiling is the basis for determining, assuring the quality, safety, and efficacy of drug substances
Planning is one of the necessary skills in both work and life if you want to handle work effectively, and systematically, increase initiative, and control as well as easily cope if faced with a difficult situation and deal with the risks. Planning is not only good for you personally but is especially useful in an
The following below contents do not contain the full and detailed information of the circular, but the information is extracted and summarized briefly as a part of the circular on chemical drugs and biological products in the public tender system. Besides a separated tender group for the original branded products (or the originator), there are
Since 2008, Vietnam has been classified as a pharmerging country, according to IMS Health (IQVIA). Pharmaceutical spending per capita in Viet Nam is relatively low but has increased dramatically in recent years. In 2005: 9,85 USD (equivalent to about 227.000 VND), in 2014: 34,48 USD (equivalent to about 793.000 VND), forecasted to reach to 163
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised pro- cedure) alongside national procedures based on different EU Member States working together and recognizing each other’s evaluations (the so-called decentralised and mutual recognition procedures). It is a system that has evolved over the past half-century
Several important uses of Quality Risk Managementin GMP practice Quality Risk Management is increasingly becoming an integral part of an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality and business. It also facilitates continual improvement and is a good tool for knowledge management.
2. COMPARATOR DRUGS SOURCING PROCESS 2.3. Identification of the supply strategy to be used 2.3.1. Selection and communication of a comparator for a clinical trial The comparator sourcing process should begin approximately 9-12 months before the comparator is received. This should allow for contingency and to identify the best strategic option for the complete duration
1. INTRODUCTION 1.1. Overview A comparator drugs, also known as a reference drug, is one that is included in a clinical study for the purpose of making comparisons of its performance in a defined population. Comparisons may be made in terms of a combination of factors such as: Efficacy, safety, ease of use, patient compliance.
