Current Issue : October-December Volume : 2012 Issue Number : 4 Articles : 5 Articles
Training is recognized in the preamble to the current good manufacturing practice regulations as a dynamic process that cannot be satisfied by a single training course to be given to an employee at the time of hire. Training should be a dynamic process, in respect to both, the training an employee receives during his or her career with a firm, and in terms of ensuring that training programmes and materials keep pace with job requirements and performance expectations. Training is an investment in people that pays its dividends in a more skilled workforce, improved productivity, and higher levels of product and service quality....
Present study investigated correlation of EGFR (epidermal growth factor receptor) mutation status with gefitinib response rate used as second-line therapy in patient with metastatic non-small-cell lung cancer. 20 Patients with non-small cell lung cancer with stage IV on Gefitinib as second line therapy for more than 3 months were enrolled from Vedanta Institute of Medical Sciences, Ahmedabad, Gujarat. EGFR mutations in exons 18 to 21 were analyzed by DNA sequencing of paraffin embedded tumor tissues. EGFR mutational status of tumors and clinical data were collected. 14 (70%) out of 20 tumors had EGFR domain mutations. 9 (64%) out of 14 cases with mutated type showed sensitivity to Gefitinib, while 3 of 6 cases without EGFR mutation showed sensitivity to Gefitinib. The median progression free survival for patients with EGFR mutation (8.08 ± 2.67) was significantly longer than patients without EGFR mutations (5.25 ± 0.707). Patients with adenocarcinoma (76 %) are more EGFR positive than non-adenocarcinoma (57%). However, there was no significant difference in smoking status, pathological features, responders and non-responders between patients with EGFR mutation and those without mutation were observed. Overall response rate (complete or partial response) was 60 % and overall disease control rate (complete or partial response + stable disease) was 75%. Gefitinib demonstrated significant antitumor activity with a favorable toxicity profile for pretreated Indian patients with advanced NSCLC. The active mutation of EGFR domain was not strongly associated with response to Gefitinib but significantly prolonged progression free survival of the patients....
The regulatory affairs in healthcare industries is comparatively new & very vital profession constituted by different government regulatory bodies to protect public health, by enhancing or controlling the safety and efficacy of healthcare products that are available worldwide. The one who is dealing with this profession is called as Regulatory Persons or Professionals that are employed in industry, government and academic and are involved with a wide range of products, including pharmaceuticals, veterinary medicines, medical devices, diagnostic services, biologics & biotechnology, pesticides, agrochemicals, cosmetics, & nutritional products. Quality with safety is the major concern throughout this Profession. Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals. The regulatory professional''s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising and post market surveillance....
Organoleptic properties play a very vital role in patient compliance, especially in the oral route of administration. This properties help in order to make it more acceptable to patients. A total of 500 questionnaire were distributed in the college premises with respondent rate of 450(90%).majority of respondents, 73% were aged between 18-23 years, while 269(59.5%) were female and 181(40.5%) were male. The survey was conducted in the colleges comprising of Ayurvedic, Biotechnology, Engineering and pharmacy. The survey comprised of 290 students (64.4%) including both undergraduate as well as postgraduate students. The rest were faculty members (26.6%) and administration incharge (8.8%). The basic aim of the survey was to gather information on public’s view for selecting and choosing the oral dosage form. There was mixed response for the type of oral dosage form preffered (Solid and Liquid). Most of them preferred tablet (79%) in comparison to capsules in solid and majority of them (92%) preferred syrup in comparision to suspensions. The small size of tablets and capsules was found out to be more patient compliant....
The organisms that infect the CNS itself (the brain and the spinal cord) are mainly viruses and bacteria, but fungi and protozoa, such as Toxoplasma and amoebae, do occasionally invade the CNS. The central nervous system is a target for a large number of viral infections. The major viruses associated with CNS infection include members of the Picornaviridae, Paramyxoviridae, Herpesviridae, Togaviridae, Flaviviridae, Rhabdoviridae, Arenaviridae, Bunyaviridae, Reoviridae, Retroviridae, and Papovaviridae families.Viruses can initiate central nervous system (CNS) diseases that include demyelination and inflammation as a major feature of neuropathology. There are no. of viral CNS diseases such as viral meningitis, viral encephalitis, Acute viral myelitis, poliomyelitis etc.Identifying the agent responsible for suspected cases of viral central nervous system (CNS) infection poses tremendous diagnostic challenges. Advanced diagnostic techniques such as neuroimaging, serology, virus culture and antigen detection, Polymerase chain reaction (PCR) are use.Now days along with Qualitative PCR-methods, quantitative, real time PCR and multiplex detection are also available.In treatment of Herpes virus Acyclovir, Vidarabin, Interferon-a are used. For CMV infections Gancyclovir, Foscarnet are used. For Paramyxo virus symptomatic treatment is only available. For Enterovirus, Pleconaril an orally active agent is used. In treatment of HIV: Antiretroviral drugs- Zidovudine, Didanosine, Stavudine are used. Also HAART (Highly Active Antiretroviral Therapy) can be helpful....
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