Posted by admin on Sep 1, 2012 in |
The globalization of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new challenges. USFDA & Industry propose generic drug user fee to address the need for globalization of the inspection process, and to speed the timely review of generic product applications. The Generic Drug User Fee (GDUF) proposal is agreed by generic industry & USFDA and is focused on three key aims: safety, access, and transparency. Under the program, USFDA will receive nearly $1.5 billion over five years in supplemental funding through generic industry user fees in order to help the agency expedite access to generic drugs, enhance drug quality and safety and ensure inspection parity of both foreign and domestic manufacturing sites. GDUF also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages. The GDUF new legislation is a milestone for the generic giants and a...
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Posted by admin on Sep 1, 2012 in |
Validation is an integral part of quality assurance; the product quality is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. Recently validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization, facilities and processes involved in pharmaceutical manufacturing process impact significantly on the quality of the products. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate...
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Posted by admin on Sep 1, 2012 in |
Pregnancy can be the most paranormal and exciting time for expectant mother. Nature provides us with many tools for supporting both the mother and baby through this time of growth and renewal, to strengthen the spirits and body to promote a healthy pregnancy and birthing process. Pregnant and lacting mother need to be educated on the need for caution when using herbs during pregnancy and lactation particularly in view of lack of complete information. The women self administer herbal medicines both before and after pregnancy often without any recognition of their potential hazards. The use of herbal supplements in pregnancy and lactation is likely to be relatively high and its importance ascertains what supplements women are taking. Pregnancy and lactation care providers should be aware of common herbal supplements used by women and of evidence regarding potential benefits or harm. Midwives and obstetricians have an obligation to facilitate women’s wishes without condemnation, but this must be tempered with accurate information to ensure that use of herbal remedies in pregnancy...
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Posted by admin on Sep 1, 2012 in |
The colon is the terminal part of the GIT which has gained in recent years as a potential site for delivery of various novel therapeutic drugs, i.e. peptides. However, colon is rich in microflora which can be used to target the drug release in the colon. Colon is a site where both local and systemic drug delivery can take place. Local delivery allows the topical treatment of inflammatory bowel disease. If drug can be targeted directly into the colon, treatment can become more effective and side effects can be minimized. These systemic side effects can be minimized by primary approaches for CDDS (Colon specific drug delivery) namely prodrugs, pH and time dependent systems and microbially triggered system which gained limited success and have limitations as compared with recently new CDDS namely pressure controlled colon delivery capsules (PCDCS), CODESTM (Novel colon targeted delivery system) osmotic controlled drug delivery system, Pulsincap system, time clock system, chronotropic system. This review is to understand the pharmaceutical approaches to colon targeted drug delivery systems...
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Posted by admin on Sep 1, 2012 in |
High performance liquid chromatography is one of the most accurate methods widely used for the quantitative as well as qualitative analysis of drug product and is used for determining drug product stability. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. A number of key chromatographic factors were evaluated in order to optimize the detection of all potentially relevant degradants. The method should be carefully examined for its ability to distinguish the primary drug components from the impurities.New chemical entities and drug products must undergo forced degradation studies which would be helpful in developing and demonstrating the specificity of such stability indicating methods.At every stage of drug development practical recommendations are provided which will help to avoid...
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