Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus...Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.展开更多
Stress during tertiary educational period has significant negative effect on the performance of a student. Mental distress is increasing among students and is one of the important public health concerns. This study wa...Stress during tertiary educational period has significant negative effect on the performance of a student. Mental distress is increasing among students and is one of the important public health concerns. This study was carried out to investigate the socio demographic characteristics of students, level of their stress feeling, and status of mental health and to find out the co-relation of different factors associated with the level of stress feelings. A cross sectional study was conducted among the students of the Department of Pharmacy of UAP. A total of 504 students (181 male students and 323 female students) participated in this study. Feeling of severe stress was almost equal to both sexes. But, moderate level of stress was more associated with female students (N = 253, F = 78.33%) and overall female students were more stressful than male. Thought towards future career ranked one among many reasons of stress in students (59.67% for male students and 37.46% for female students). In terms of academic achievements, feeling of stress was higher in female students compared to male students (34.98% for female students vs. 15.47% for male students). Other factors such as unrealistic expectations, family relationship and affairs, socio economic condition, being of too busy also significantly participate in the development of stress in young mind. Mental health status was estimated by considering some facts such as state of shock due to unwanted life events, lacking of expression of emotions, reduced feeling of pleasure, unusual thinking, fear of any specific objects, short term memory loss, self identity disorder and lack of self confidence. We co-related different risk factors like age, gender, socio-economic condition, unrealistic thought patter to different levels of stress feeling. Feelings of stress were most among the student of 21 - 25 years of age. Socio-economic condition is always a great factor of stress, middle class society has more stress compared to other socio-economic classes. Psychological counseling is required in educational institution to detect and prevent mental distress and stress among students.展开更多
文摘Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.
文摘Stress during tertiary educational period has significant negative effect on the performance of a student. Mental distress is increasing among students and is one of the important public health concerns. This study was carried out to investigate the socio demographic characteristics of students, level of their stress feeling, and status of mental health and to find out the co-relation of different factors associated with the level of stress feelings. A cross sectional study was conducted among the students of the Department of Pharmacy of UAP. A total of 504 students (181 male students and 323 female students) participated in this study. Feeling of severe stress was almost equal to both sexes. But, moderate level of stress was more associated with female students (N = 253, F = 78.33%) and overall female students were more stressful than male. Thought towards future career ranked one among many reasons of stress in students (59.67% for male students and 37.46% for female students). In terms of academic achievements, feeling of stress was higher in female students compared to male students (34.98% for female students vs. 15.47% for male students). Other factors such as unrealistic expectations, family relationship and affairs, socio economic condition, being of too busy also significantly participate in the development of stress in young mind. Mental health status was estimated by considering some facts such as state of shock due to unwanted life events, lacking of expression of emotions, reduced feeling of pleasure, unusual thinking, fear of any specific objects, short term memory loss, self identity disorder and lack of self confidence. We co-related different risk factors like age, gender, socio-economic condition, unrealistic thought patter to different levels of stress feeling. Feelings of stress were most among the student of 21 - 25 years of age. Socio-economic condition is always a great factor of stress, middle class society has more stress compared to other socio-economic classes. Psychological counseling is required in educational institution to detect and prevent mental distress and stress among students.
