Inserting Sample on NMR Magnet

2011-01-03T16:46:00.000+05:30

Inserting 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&

Preparation of NMR Buffers Protocol

2011-01-03T16:33:00.000+05:30

3. 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)

Clinical Trial in Nut Shell

2010-12-29T13:44:00.002+05:30

Screening and Recruitment of Study Subjects in Clinical Research

2010-12-29T12:39:00.003+05:30

Screening 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

Study Subjects Data and Documents For Clinical Research

2010-12-29T12:32:00.002+05:30

Study Subjects Data and Documents For Clinical Research Ø All signed and dated informed consent forms (for enrolled and screened subjects).Ø Study subject screening and/or enrolment log.

During the clinical research studies

2010-12-29T12:27:00.000+05:30

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

Probe Tuning :NMR

2010-12-29T11:56:00.001+05:30

Probe 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

Prepare the required documents to be submitted to the IEC/IRB: according to ICH

2010-12-25T16:43:00.003+05:30

Prepare 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

Make sure that the local ethics committee fulfils the ICH GCP requirements. ICH GCP Composition and Operations of IEC/IRB

2010-12-25T16:41:00.002+05:30

Make 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:Ø A reasonable number of

PRIOR TO INITIATION OF THE CLINICAL RESEARCH STUDY

2010-12-25T16:39:00.001+05:30

PRIOR 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/

Operating procedure for NMR spectrometer : Bruker Avance DPX-300 NMR spectrometer

2010-12-25T11:15:00.001+05:30

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

(ICH definition – International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use)

2010-12-24T15:39:00.000+05:30

(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

Reconciliation of the Serious Adverse Events

2010-12-24T15:18:00.000+05:30

Reconciliation 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, the

Conduct of Clinical Research study

2010-12-24T15:09:00.000+05:30

Conduct 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

Base line drift, Base line noise, Broad peaks, Change in height, Negative peaks, Ghost peaks in HPLC

2010-12-21T15:34:00.000+05:30

Base line drift What You Expect What You Got Disease Medicine Fluctuation of column temperature Stabilize. Use column oven Contamination of mobile phase/

Peak tailing, Peak Fronting, Rounded Peaks in HPLC chromatogram

2010-12-20T16:07:00.000+05:30

Peak 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 volume

Peak splitting

2010-12-20T15:53:00.000+05:30

Peak 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

Retention times are not constant

2010-12-20T15:19:00.000+05:30

Retention times are not constant What you Expect What you Got Disease Medicine Leak Check for loose fittings

No Pressure or Pressure Lower than anticipated

2010-12-20T15:03:00.000+05:30

No 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 Check

No Peaks or view Small Peaks in HPLC

2010-12-20T12:34:00.000+05:30

No Peaks or view Small Peaks in HPLC What You Expect What You got

Research and Development