tag:blogger.com,1999:blog-65772627137725991832024-02-25T12:59:54.546+05:30Research and DevelopmentR&D is creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society thus in R&D investigative activities that a business chooses to conduct with the intention of making a discovery that can either lead to the development of new products or procedures, or to improvement of existing products or procedures.Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.comBlogger82125tag:blogger.com,1999:blog-6577262713772599183.post-30014583551441117452011-01-03T16:46:00.000+05:302011-01-03T16:46:25.722+05:30Inserting Sample on NMR MagnetInserting Sample 1. NMR tube containing sample should be held in a plastic spinner (use the blue color spinner in 500 and 600 MHz spectrometers; use the white color spinner in 700 MHz spectrometer). Hold the sample&Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com2tag:blogger.com,1999:blog-6577262713772599183.post-301366705963371322011-01-03T16:33:00.000+05:302011-01-03T16:33:02.078+05:30Preparation of NMR Buffers Protocol3. Preparation of NMR Buffers Protocol:3.1.Stock Solutions: 3.1.1 0.1M stock solution of Na2HPO4. Weigh 141.96g of Na2HPO4 (anhydrous) and dissolve to 1000 ml (one Liter) with ddH2O.3.1.2 0.1M stock solution of NaH2PO4. Weigh 119.98g of NaH2PO4 (anhydrous) Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com1tag:blogger.com,1999:blog-6577262713772599183.post-61935890873368300252010-12-29T13:44:00.002+05:302010-12-29T13:44:57.596+05:30Clinical Trial in Nut ShellResearch and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com3tag:blogger.com,1999:blog-6577262713772599183.post-75411729116855670372010-12-29T12:39:00.003+05:302010-12-29T12:59:19.850+05:30Screening and Recruitment of Study Subjects in Clinical ResearchScreening and Recruitment of Study Subjects
It is important that the Investigator resolves all questions from his/her staff concerning the interpretation of inclusion/exclusion criteria.The Investigator should be able to dedicate time to the recruitment of suitable trial subjects – the consultation time for recruitment of each subject is likely to be longer than the time required for normal Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com4tag:blogger.com,1999:blog-6577262713772599183.post-24911758823680403082010-12-29T12:32:00.002+05:302010-12-29T12:32:25.238+05:30Study Subjects Data and Documents For Clinical ResearchStudy Subjects Data and Documents For Clinical Research
<!--[if !supportLists]-->Ø <!--[endif]-->All signed and dated informed consent forms (for enrolled and screened subjects).<!--[if !supportLists]-->Ø <!--[endif]-->Study subject screening and/or enrolment log.<!-Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-68513799429804557562010-12-29T12:27:00.000+05:302010-12-29T12:27:02.001+05:30During the clinical research studies
The trial can be initiated (begin screening and/or enrolment of trial subjects) only after the Clinical Monitor has satisfactorily conducted a Trial Initiation Monitoring Visit and the TDR Clinical Coordinator has given written authorization.
Investigator’s File, Including Storage and RetentionOn initiation of the study, the Investigator must prepare a file containing documents related to the Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-1054162041048627492010-12-29T11:56:00.001+05:302010-12-29T12:30:22.456+05:30Probe Tuning :NMRProbe Tuning :NMR
Probe tuning must be matched to the sample in order to minimize pulse widths and maximize sensitivity. Although the effects are small for routine proton spectra, they can be dramatic for more complex pulse sequences. Although the tuning changes between different organic solvents usually do not justify the effort to tune, if you are changing from an organic solvent Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-39699100559632354422010-12-25T16:43:00.003+05:302010-12-25T16:47:34.435+05:30Prepare the required documents to be submitted to the IEC/IRB: according to ICHPrepare the required documents to be submitted to the IEC/IRB:
Documents usually required by Ethics Committees· Investigator Brochure and up-to-date safety information.· Trial protocol (final version and amendments).· Consent form(s) and subject information sheets.· Subject recruitment procedures (e.g. advertisement· Information on Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-82430573536075218202010-12-25T16:41:00.002+05:302010-12-25T16:41:44.169+05:30Make sure that the local ethics committee fulfils the ICH GCP requirements. ICH GCP Composition and Operations of IEC/IRBMake sure that the local ethics committee fulfils the ICH GCP requirements.ICH GCP Composition and Operations of IEC/IRB
The IRB/IEC should determine the authority under which it is established and the composition (names and qualifications)of its members, which should consist of:<!--[if !supportLists]-->Ø <!--[endif]-->A reasonable number of Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-86832096407505761022010-12-25T16:39:00.001+05:302010-12-25T16:55:15.190+05:30PRIOR TO INITIATION OF THE CLINICAL RESEARCH STUDYPRIOR TO INITIATION OF THE CLINICAL RESEARCH STUDYThe Investigator should:Be interested in the scientific aspects of the study and ensure that the study is responsive to the needs of public health within the country of the population in which it will be conducted.
Ensure the confidentiality of the product, the protocol and trial procedures by giving a confidentiality agreement in writing to TDP/Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-85793206061413258342010-12-25T11:15:00.001+05:302010-12-25T11:18:58.790+05:30Operating procedure for NMR spectrometer : Bruker Avance DPX-300 NMR spectrometer
Note:
Unless otherwise specified, statements such as “click on calib” mean to move the cursor on top of the calib button on the screen, and click with the left-hand mouse button. Consider the left-hand mouse button the default; if another button is required, it will be explicitly stated.
Commands such as “Enter zg” mean to type zg followed by a return on thekeyboard. Commands must be Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-30769173749172012052010-12-24T15:39:00.000+05:302010-12-24T15:39:28.474+05:30(ICH definition – International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)(ICH definition – International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)
Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or a product’ s new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-88387896943470195312010-12-24T15:18:00.000+05:302010-12-24T15:18:54.450+05:30Reconciliation of the Serious Adverse EventsReconciliation of the Serious Adverse Events
Requirement:
3.1 Reconciliation of SAEs captured during the conduct of clinical research trials and SAEs recorded in the Safety Database will occur several times during the lifecycle (the conduct) of the clinical research trial. 3.2 Timing and number of the reconciliation cycles will be determined by the frequency of data received, theResearch and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-14610053842802059182010-12-24T15:09:00.000+05:302010-12-24T15:09:09.065+05:30Conduct of Clinical Research studyConduct of Clinical Research study
Role Responsibility
Study Coordinator Maintain and update the study plan for managing clinical data collected in accordance with protocol specifications and/or requirements. Receive data and log receipt of CRFs in a timely and appropriate manner. Transfer or hand-over received CRFs to the relevant entry personnel for Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com1tag:blogger.com,1999:blog-6577262713772599183.post-71521891553394588572010-12-21T15:34:00.000+05:302010-12-21T15:34:00.683+05:30Base line drift, Base line noise, Broad peaks, Change in height, Negative peaks, Ghost peaks in HPLCBase line drift
What You Expect What You Got
Disease Medicine
Fluctuation of column temperature Stabilize. Use column oven
Contamination of mobile phase/Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-18685750274692308472010-12-20T16:07:00.000+05:302010-12-20T16:07:57.409+05:30Peak tailing, Peak Fronting, Rounded Peaks in HPLC chromatogramPeak tailing
What you expect What you Got
Disease Medicine
Active sites within the column Test with standard test mixture. If OK add competing base or acid modifier
Wrong pH Correct
Wrong column Change
Void volumeResearch and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-19131494549637929952010-12-20T15:53:00.000+05:302010-12-20T15:53:15.613+05:30Peak splittingPeak splitting
What you Expect What you Got
Disease Medicine
Contamination of column or guard Remove guard column. If the problem is solved replace it. If not go next
Plugged column Use adequate recovery procedure. If the problem Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-42038267920089464762010-12-20T15:19:00.000+05:302010-12-20T15:19:13.616+05:30Retention times are not constantRetention times are not constant
What you Expect What you Got
Disease Medicine
Leak Check for loose fittings
Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-15028210865069102842010-12-20T15:03:00.000+05:302010-12-20T15:03:34.832+05:30No Pressure or Pressure Lower than anticipatedNo Pressure or Pressure Lower than anticipated
What you Expect. What you got
Disease Medicine
Leak Check for loose fittings
Check pump for leaks, salts and noise
CheckResearch and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-7092525024003946122010-12-20T12:34:00.000+05:302010-12-20T12:34:36.984+05:30No Peaks or view Small Peaks in HPLCNo Peaks or view Small Peaks in HPLC
What You Expect What You got
<!--[if gte mso 9]> Normal 0 false false false MicrosoftInternetExplorer4 Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-15591110929894368912010-12-20T11:19:00.001+05:302010-12-20T11:39:29.912+05:30Operating Procedure of BRUKER AUTOFLEX MALDI-TOF Mass SpectrometerOperating Procedure of BRUKER AUTOFLEX MALDI-TOF Mass Spectrometer
1. Press Ctrl-Alt-Del and enter your name and password to log into the computer. Allow
time (30-60 s) for background processes to start.
2. Exit the WinTV application by clicking a cross in the right top corner of the window.Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-26527286576094536632010-12-18T17:20:00.000+05:302010-12-18T17:20:17.500+05:30Method Development in UHPLCMethod Development in UHPLC The rules for developing a new method in UHPLC are slightly different from those of conventional HPLC because it is necessary to account for the backpressure constraint generated by the use of small particles.
3.1. Choice of column dimensions Depending on the supplier, it is possible to find some columns dedicated to UHPLC with internal diameters of 1, 2.1 and Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com0tag:blogger.com,1999:blog-6577262713772599183.post-73141914741033903852010-12-18T16:54:00.000+05:302010-12-18T16:54:29.963+05:30HPLC: Analytical Method VallidationMethod validation. Proper validation of analytical methods is important for pharmaceutical analysis when ensurance of the continuing efficacy and safety of each batch manufactured relies solely on the determination of quality. The ability to control this quality is dependent upon the ability of the analytical methods, as applied under well-defined conditions and at an established level of Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com1tag:blogger.com,1999:blog-6577262713772599183.post-45672489735419411132010-12-18T15:06:00.000+05:302010-12-18T15:06:56.329+05:30Optimizing the Separation : HPLCOptimizing the Separation
Once you have a separation you may want to optimize it. You may wish to shallow out the gradient to improve the separation, or you may wish to shorten the run time. Taking the illustration above one can see that all of the peptides are out by 40 minutes. This does not mean that we can change this 80 min run into a 40 min run, but there is room for Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com1tag:blogger.com,1999:blog-6577262713772599183.post-43083695983893749182010-12-18T15:02:00.000+05:302010-12-18T15:02:08.893+05:30HPLC: TutorialIntroduction
The message of this tutorial is that reverse phase HPLC is simple. Compounds stick to reverse phase HPLC columns in high aqueous mobile phase and are eluted from RP HPLC columns with high organic mobile phase. In RP HPLC compounds are separated based on their hydrophobic character. Peptides can be separated by running a linear gradient of the organic solvent.&Research and Developmenthttp://www.blogger.com/profile/17948129999817246319noreply@blogger.com1