Technology Transfer a Global Perspective: Crux of the Matter
Ramesh S. Yamgar,
Sudhir S. Sawant
Issue:
Volume 2, Issue 3, June 2014
Pages:
27-37
Received:
29 April 2014
Accepted:
26 May 2014
Published:
10 June 2014
Abstract: Technology transfer has become a key activity in the pharmaceutical manufacturing domain. The processes are developed in an R&D set up for the API or finished dosage forms and are transferred to another site in the same country or different geographic location. Due to changing business needs, technology transfer has become a global activity and opens up various opportunities for the professionals in pharmaceutical domain. The coordination of various linked activities like procurement, quality , production, health & safety of the personnel involved in manufacturing and export have become more vital. This article discuss about various aspects of technology transfer like outsourcing key raw materials, information security to protect the intellectual property, various development strategies for API development and most significantly the practical difficulties encountered during API technology transfer. It is also describing certain trouble shooting issues, which were resolved with the help of reaction mechanism & chemistry involved in processes and investigations made to arrive at appropriate CAPA. This article is also indicating simple laboratory techniques/ instruments, which could be adopted to support PAT initiatives. It is also describing examples of how certain process improvements were achieved due to trouble shooting in scale up trial batches.
Abstract: Technology transfer has become a key activity in the pharmaceutical manufacturing domain. The processes are developed in an R&D set up for the API or finished dosage forms and are transferred to another site in the same country or different geographic location. Due to changing business needs, technology transfer has become a global activity and ope...
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Logistic Simulation of the Bogie Bracket Welding Production Line Using the RaLC Software
Geng Hai-yang,
Luo Yi-ping,
Ren Hong-juan,
Xu Biao
Issue:
Volume 2, Issue 3, June 2014
Pages:
38-42
Received:
18 May 2014
Accepted:
5 June 2014
Published:
20 June 2014
Abstract: Based on the process design and the production program, the 3D simulation model of the bogie bracket welding production line is built by RaLC. This model was built for the practical problem of the manufacturing logistics design of a bulldozer company joint workshop in Shanghai. The modeling and simulation technique is applied in this process. Then the bogie bracket welding production line is simulated and designed by RaLC. This study puts forward an improvement plan for the bottleneck process in the production line through the analysis of the simulation results, which achieves the optimization design goal of the production line.
Abstract: Based on the process design and the production program, the 3D simulation model of the bogie bracket welding production line is built by RaLC. This model was built for the practical problem of the manufacturing logistics design of a bulldozer company joint workshop in Shanghai. The modeling and simulation technique is applied in this process. Then ...
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Developing of Prediction Models for Soil Profile and Its Parameters Using Artificial Neural Networks
Hussein Elarabi,
Nahed F. Taha
Issue:
Volume 2, Issue 3, June 2014
Pages:
43-48
Received:
22 May 2014
Accepted:
9 June 2014
Published:
20 June 2014
Abstract: Artificial neural networks (ANNs) are a form of artificial intelligence (AI), which in their architecture attempt to simulate the biological structure of the human brain and nervous system. In this report, back-propagation neural networks are used to predict soil classification and soil parameters of Khartoum State. The study was based on the available data collected from specified areas in Khartoum, and then the results were compared with data brought from actual boreholes to check the ANN model validity. The results indicate that artificial neural networks are a promising method in predicting soil classification and soil parameters of Khartoum State.
Abstract: Artificial neural networks (ANNs) are a form of artificial intelligence (AI), which in their architecture attempt to simulate the biological structure of the human brain and nervous system. In this report, back-propagation neural networks are used to predict soil classification and soil parameters of Khartoum State. The study was based on the avail...
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Ethanolic Extracts of Vitex Doniana Possesses Hepatocuractive Property in Poloxamer Induced Hyperlipidemia
Victor Duniya Sheneni,
Dorcas Bolanle James,
Sunday Eneojo Atawodi
Issue:
Volume 2, Issue 3, June 2014
Pages:
49-54
Received:
25 April 2014
Accepted:
28 May 2014
Published:
20 June 2014
Abstract: The hypolipidemic effect of Vitex doniana ethanolic leaves, stem bark and root bark extracts on some biochemical parameters in Poloxamer 407 (P407) induced hyperlipidemic rats was studied for a period of 21 days. Fifty four mixed sex rats weighing 100-200g were divided into nine groups comprising six animals per group: group given feed and water only, group induced by an intra-peritoneal injection of P407 every 48 hours without treatment, groups induced and treated with atorvastatin, leaves, stem bark, root bark extracts and groups of normal rats treated with leaves, stem bark and root bark extracts without induction. In all the groups, P407, atorvastatin, leaves, stem bark and root bark extracts were administered at a dose of 1000mg/kg, 20mg/kg, 100mg/kg, 100mg/kg and 30mg/kg body weight respectively. Blood samples were collected from the rats in all the groups at the end of the 21 days of treatment for determination of serum levels of; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total protein (TP), total bilirubin (TB), indirect bilirubin (IB) and direct bilirubin (DB) using Randox kits. Serum concentration of liver marker enzymes (AST, ALT and ALP) was significantly (p<0.05) higher in hyperlipidemic control group when compared to normal control and all treated groups. However there was a significant (p<0.05) decrease and non-significant (p>0.05) change in the levels of these marker enzymes in hyperlipidemic groups treated with the extracts and normal treated groups when compared with the hyperlipidemic and normal control group respectively. There was a significantly (p<0.05) lower level of TP, DB and a significantly (p<0.05) higher level of TB, ID in hyperlipidemic group when compared with rats in the normal control and all treated groups. Normal groups treated with the extracts without induction shows a non-significant (p>0.05) difference in TP, DB, TB and ID when compared with normal control group. These results highlight the efficacy of Vitex doniana (leaves, stem bark and root bark) ethanolic extracts in the amelioration of some undesirable effects of hyperlipidemia.
Abstract: The hypolipidemic effect of Vitex doniana ethanolic leaves, stem bark and root bark extracts on some biochemical parameters in Poloxamer 407 (P407) induced hyperlipidemic rats was studied for a period of 21 days. Fifty four mixed sex rats weighing 100-200g were divided into nine groups comprising six animals per group: group given feed and water on...
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