The development of new drugs and medical devices has been attributed to constant innovation, and the medical device industry in particular is growing faster than the drug industry. The medical device market in Korea is growing, with an average annual growth rate of 12.6% from 2006 to 2008. The production amount of medical devices categorized as Class 3 or Class 4 increased more rapidly than Class 1 or Class 2 with an increase in portion size. Clinical trials are a crucial process through which the safety and efficacy of medical devices is evaluated prior to allowing them to be used by the public. Recently, the approval rate of clinical trials for medical devices by the Korea Food & Drug Administration has increased, indicating that clinical trials that could be scientifically feasible and ethically justified were planned. To satisfy the increasing need for high quality clinical trials, a total of 6 medical device clinical trial center consortia have been designated by the Ministry of Health & Welfare as of July 2010. Medical devices take significantly less time to get to the market compared to drugs and there is much need for innovation. Therefore, the clinical trial market for new medical devices is expected to grow faster than previously forecast.
Drug Industry ; Korea

After The 6th Party Congress, Vietnam pharmaceutical industry prospered, especially in 1990s. Pharmaceutical industry was rising; drug market in Vietnam became eventful and plentiful, responded more and more effectively for the healthcare needs of people. The author mentioned situations of pharmaceutical production and trade in Vietnam during 1996-2002 period: kinds of pharmaceutical companies, situation of drug use, situation of production and trade of Vietnamese pharmaceutical companies and ensuring drug quality
Drug Industry ; Pharmaceutical Preparations

Objects: labour force capital and labour market in some pharmaceutical manufacturing enterprises during years of 1991-1994. Methods: efficacy of working, labour cost, studying and building a period of business, manufacture. High evaluation on needs of human resource, who were trained to become enough standard for moral and talent in arranged sites and close technical process.
Pharmaceutical Preparations ; Drug Industry

No abstract available.
Drug Industry* ; Prescriptions*

No abstract available.
Drug Industry* ; Prescriptions*

Overtaking and coming to meet are a challenge to the Vietnamese pharmacentical industry on the road of integration. A large system such as Vietnam’s pharmaceutical system can cover various smaller system existing in diverse periods of development. Therefore overtaking and coming to meet is a challenge to Vietnam’s pharmacentical industry on the road of international integration. In our country, apart from the slogan of “overtaking the developed countries” there is an other slogan of “coming to meet”. Coming to meet the level of some leading branches of technology is an essential task, needing the concrete and strick management of MOH for developing the pharmacentical system by the years 2005, 2010…; assuring its important position in our national economy
Drug Industry ; Vietnam ; Pharmaceutical Preparations

This paper introduced and classify the common mistakes in the study and use of pharmaceutical materials including mistakes due to the same form, due to the processing that changed the primary form of materials, casual distribution of materials, identical name, identification of botanical resources, imitate materials and lack of knowledge of material resources.
Pharmacy ; Medical Errors ; Drug Industry

Process validation is strictly required in good manufacturing practice. For doing so, Shewhart charts can be used effectively. In this work, two types of Shewhart charts including X-bar chart and R chart were applied to validate the production processes of Rantitidin tablets and Tryotricin lozenges. By using six rules of evaluation, the statistical process control of the mean tablet weights were clearly shown
Pharmaceutical Preparations ; Tablets ; Drug Industry

The objectives of prospective process validation are to evaluate the key variables and their operational ranges and to predict the "worst cases" for each investigated variable. The targets of formulation design and optimization are to establish the quantitative relationships between input variables (ingredients/ processing conditions) and output variables (product properties). There are some intersectional ideas between validation and optimization as input-output relationships, quantifiable and predictable behaviours of input and output variables, constraints of independent and dependent variables, etc. The formulation design and optimization for paracetamol tablets, in combination with process prospective validation, using the optimization and what if prediction performed by INForm v3.0 as a frame work, was successfully done to (a) determine the critical variables as well as to estimate their optimized values, (b) to investigate the variable limits as well as to predict some worst cases
Pharmaceutical Preparations ; Formularies ; Drug Industry

Validation is an essential requirement of GMP in current World. Requirement of GMP Validation of ASEAN: (1) Validation on manufacturing process. (2) Validation on quantitative method. 3. Validation on equipment. 4. Validation on hygienic standard and hygienic procedures. Results: (1) Guarantee manufacture to have a products, which respond regulated quality. (2) Respond regulated requirement of decree
Jurisprudence ; Pharmaceutical Preparations ; Drug Industry