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Mrs. Arpana Prasad, our method development head shares her experience on AAPS workshop at Washington DC |
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Arpana at AAPS |
Arpana with AAPS Attendees |
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The workshop provided latest information to the participants on certain topics such as 1) incurred sample repeat reanalysis: regulatory perspective, 2) Incurred sample reanalysis: is it insurance for a weak assay?, 3) how to select samples for reanalysis, 4) when & how to demonstrate assay reproducibility, 5) outcomes & consequences of incurred sample reproducibility assessment, 6) Acceptance criteria for incurred sample reanalysis.
The presentations were made by speakers from US food & drug administration & various pharmaceutical companies. The topics were presented by Jacqualine O’ Shanghnessy (USFDA), C.T. Vishwanathan (USFDA), Douglas M. Fast & John Smeraglia (Pfizer), Surendra Bansal (Hoffmann La Roche), Min Chang (Abbot Lab Inc), QinJi (Covance Laboratories), Salen Hussain (Anapharm), Anthony J Stelano (US Pharmacopeia) Ajai Chaudhary (Eli Lilly & Company).
Attending AAPS workshop on assay reproducibility incurred samples was a great experience learning the views of industry & regulatory members. This workshop provided the opportunity to meet various members of FDA as well as representatives of various pharmaceutical companies. The brainstorming sessions provided valuable inputs for implementing the assessment of reproducibility in incurred samples which in turn would help us know that our bioanalytical method is precise, accurate and gives reproducible results. This workshop provided an insight of how & when to establish ISR for clinical samples and what are pros and cons of it. |
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BA Research Our method development team has developed new assays for Valacyclovir & Acyclovir, Trazodone & M-CPP, Imipramine & Desipramine, Tacrolimus, Propafenone and OH-Propafenone, Metformin, Niacin and Nicotinuric acid. The full lists of assays are available on website |
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BA Research India conducts a transdermal application study on postmenopausal females |
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Relative bioavailability, wear and adhesive properties of TDS (Transdermal delivery system) were studied in postmenopausal healthy female subjects.
The protocol had stringent criteria and BA met the social challenges of recruiting elderly female population with the help of dedicated and experienced staff. Apart from this, other activities according to protocol were meticulously executed through planning and co-ordination, ensuring complete protocol compliance. The study successfully completed within stipulated timelines ensuring 100% subject compliance. |
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Mr. Bhavin Patel, our method development team member has published a research paper in Journal of separation Science |
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The research paper on “Simultaneous determination of simavastatin and simavastatin acid in human plasma by LC-MS/MS without polarity switch: Application to a bioequivalence study” is published in Journal of Separation Science, Volume 31, Issue 2, Pages 301-303, online on :14 Jan 2008. Web Link: http://www3.interscience.wiley.com/cgi-bin/abstract/117885037/ABSTRACT |
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First from left, Mr. Ghanshyam Patel |
hgg Mr. Ghanshyam Patel, our biostatistician has attended training on “SAS® Programming I: Essentials” The training provided guidance on the use of new functions of the SAS 9.1 version such as, to investigate and summarize data by generating frequency tables and descriptive statistics, to combine multiple SAS files, to create listing, summary, HTML & graph reports. |
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Visit us : http://www.baresearchindia.com Contact us : vijay@baresearchindia.com |