Analytical chemistry ebook download

InTeOp | 2012 | ISBN: 9535108375 9789535108375 | 154 pages | PDF | 8 MB

The current text deals with several, very important topics of modern, Analytical Chemistry, such as analytical method validation in biotechnology today, principal component analysis, kinetic methods of analysis using potentiometric and spectrophotometric detectors, the current status of Analytical Chemistry and where it may move in the future, peptide and amino acid separations and identification, and several other, related topics in this growing and increasingly important area of Chemistry, in general.

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http://longfiles.com/m7o2lcme88se/AnalyticalChemistryITO12.pdf.html

http://longfiles.com/m7o2lcme88se/AnalyticalChemistryITO12.pdf.html

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Serum Institute of India acquires rights to TB vaccine

New Drug Approvals

Serum Institute of India acquires rights to TB vaccine

Serum Institute of India, a Pune-based manufacturer of vaccines, is planning on taking a promising vaccine – originally developed in Germany – and introducing it into the clinic. Studies have shown that the new vaccine is more effective and better tolerated than currently available options.

By signing a contract with Hannover-based Vakzine Projekt Management (VPM), Serum has secured the licence to the various patents and technologies related to the…

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Kiran Mazumdar-Shaw, chairman and managing director of Indian biopharma giant Biocon propels company to clock revenue worth $121 mn

New Drug Approvals

Kiran Mazumdar-Shaw, chairman and managing director, Biocon.

Kiran Mazumdar Shaw: She has the odd passion—artwork, horses—but it’s Biocon that really gives her joy

What do our other billionairesses like to splurge on? Kiran’s abiding passion, apart from her work, are horses and paintings—she particularly enjoys collecting the works of Yusuf Arakkal and S.G. Vasudev. Sailoja confesses she loves Louis Vuitton purses and diamond and gold jewellery. “But I haven’t bought any great jewellery for two years now,” she says. Shobhana admits to a weakness for designer watches and bags, as well as light, trendy and stylish fashion jewellery which is not necessarily very expensive. Ekta loves dressing up—but of course her biggest pleasure comes from watching her audience ratings soar.

For most, making billions is not what drives them. Sulajja, who recently sold a 15 per cent stake in her company to Anil Ambani’s Reliance Capital, could be speaking for…

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RBX2660-Rebiotix Receives FDA IND Approval to Begin Phase 2 Trial of Pioneering Microbiota Restoration Therapy

RBX2660

Rebiotix Receives FDA IND Approval to Begin Phase 2 Trial of Pioneering …
The Herald | HeraldOnline.com
Rebiotix Inc. announced today that the U.S. Food and Drug Administration has approved the company’s Investigational New Drug (IND) application to begin the Phase 2 clinical study of RBX2660 for the treatment of recurrent Clostridium difficile infection …http://www.heraldonline.com/2013/07/29/5064322/rebiotix-receives-fda-ind-approval.html

CLOSTRIDIUM

Generic drugs in Portugal can now be launched monthly rather than quarterly

July 29 2013 | By Márcio Barra

Portuguese generic drug makers will now be able to introduce new generic drugs into the market every month and not just quarterly, in another move by the Portuguese Ministry of Health to increase the market share of generics and reduce state drug expenditure.

Ordinance n.º 103/2013 from 26 July 2013 , changes “the mechanisms of creation of homogeneous groups and respective reference prices, aiming to maximize savings resulting from a greater incentive for generics use and promote an increase of market share in line with the international commitments of the Portuguese State, “reads the preamble of the statute. This ordinance updates Decree-Law n. -A/2010 48, already amended by Decree-Law n.º 106 -A/2010 and Law n. º 62/2011.

According to the Ordinance, the calculation and publication of the reference price of new homogeneous groups created as a result of the market introduction of new…

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Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw

Kiran Mazumdar-Shaw, MD, BIOCON

 

Indian Pharma Market Needs Strong Regulatory Set-up:   Kiran Mazumdar-Shaw, MD, BIOCON

 

Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:

READ ALL AT

http://kiranmazumdarshaw.blogspot.in/2013/07/indian-pharma-market-needs-strong.html

EMA approves 8 new medicines for Europe

July 29 2013 | By Márcio Barra

EMA’s CHMP 22-25 July 2013 saw 8 new drugs obtaining a positive opinion for a marketing authorization (MA). Here is the rundown of approvals:

Approved marketing authorizations for new drugs:

Giotrif (afatinib), Boehringer Ingelheim International GmbH  –  Giotrif is an antineoplastic drug for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations. The drug is the first irreversible ErbB family blocker, a group of receptor tyrosine kinases overexpress in many cancers. This is the third drug to target EGFR mutations in NSCLC, joining erlotinib (Tarceva) and gefitinib (Iressa).

The CHMP’s positive opinion for Giotrif is based on data from the pivotal trial LUX-Lung,comparing afatinib to chemotherapy with pemetrexed/cisplatin. Results from the study showed that patients taking afatinib lived for almost one year without their tumour growing again versus just over half a year for those treated with pemetrexed/cisplatin.

Afatinib was 

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INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS

INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS

Determine the unit operations needed to manufacture the tablets.

1. Mixing or Blending:

Materials that have similar physical properties will be easier to form a uniform mix or blend and will not segregate as readily as materials with large differences.

Parameters to consider

:read all at

………………http://pharmaresearchdevelopment.blogspot.in/search/label/Process%20Validation

more links

1. REVIEW:- INDUSTRIAL PROCESS VALIDATION OF TABLET …

   http://www.pharmatutor.org/…/review-industrial–process-validation-tablet-dosa…‎

   You are hereREVIEW:- INDUSTRIAL PROCESS VALIDATION OF TABLET …. Process Evaluation and Selection: – Determine the unit operations needed to  …

2. INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR …

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   Dec 17, 2010 – INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS: Determine the unit operations needed to manufacture the tablets. 1.

3. industrial process evaluation and selection for tablets

   networkedblogs.com/NAAPU‎

   2 hours ago – Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker (by DR ANTHONY MELVIN CRASTO Ph.D)

4. Guidance for Industry: Extended Release Oral Dosage Forms

   http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070239.pdf‎

   Guidance for Industry … Center for Drug Evaluation and Research (CDER) …. initial approval process or because of certain pre- or postapproval changes …. A suitable distribution of sampling points should be selected to define ….. Drug product: A finished dosage form, e.g., tablet, capsule, or solution, that contains a drug.

5. Guidance for Industry – Food and Drug Administration

   http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0493-gdl0001.doc‎

   Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit … Center for Drug Evaluation and Research (CDER) … Guidance for Industry[1] …. double cones, or drum mixers), samples should be selected from at least two depths along ….. In-process dosage unit is a capsule or tablet as it is formed in the  …

6. Guidance for Industry – Food and Drug Administration

   Guidance for Industry … Center for Drug Evaluation and Research (CDER) …. methods for comparing dissolution profiles; and (4) a process to help … immediate release solid oral dosage forms, such as tablets and capsules, are used to …. coefficient measurement may be useful in selecting the dissolution methodology and.

7. industrial process validation of tablet dosage form: an overview

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   evaluating, documenting, and re-evaluating a series of critical steps in the …. form5,6. The strategy selected for process validation should be Simple and straightforward. … Industrial process overview of tablet manufacturing5,6,11. Steps and  …

Submission of Summary Bioequivalence data for ANDAs

Submission of Summary Bioequivalence Data for ANDAs

read all at

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM134846.pdf

1. http://www.fda.gov/downloads/Drugs/…/Guidances/UCM134846.pdf‎

   Guidance for Industry. Submission of Summary. Bioequivalence Data for ANDAs. U.S. Department of Health and Human Services. Food and Drug Administration.

2. Bioequivalence Studies Rule Specific Products Guidance Process

   http://www.fda.gov/…/HowDrugsareDevelopedandApproved/…/AbbreviatedN…‎

   Division of Bioequivalence 2, Office of Generic Drugs. Center for … Requires ANDA applicants to submit data … Should submit a complete or summary report for.

3. 
   

   Guidance for Industry – Food and Drug Administration

   http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2009-D-0126-gdl.pdf‎

   Guidance for Industry. Submission of Summary. Bioequivalence Data for ANDAs. Additional copies are available from: Office of Communication. Division of Drug  …

4. Abbreviated New Drug Application (ANDA): Generics > Generic …

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   6 days ago – “Original Abbreviated New Drug Approvals (ANDAs) by Month” for Generic … Model Bioequivalence Data Summary Tables (PDF – 219KB) The  …

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ANDA Bioequivalence Studies That Fail to Meet FDA’s Current

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Additional guidance on documents relating to an active substance master file

Additional guidance on documents relating to an active substance master file

EMA DOWNLOAD

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/10/WC500133204.pdf

1. Guideline on Active Substance Master File – European Medicines …

   http://www.ema.europa.eu/docs/en_GB/document…/WC500002814.pdf‎

   Apr 15, 2005 – The main objective of the Active Substance Master File (ASMF) procedure, commonly known as the European Drug Master File (EDMF) …

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   Active substance master file, ASMF, letter of access, submission letter. 7 Westferry Circus … Content of the MA-dossier when the Active Substance Master File.

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4. Drug Master File – Wikipedia, the free encyclopedia

   en.wikipedia.org/wiki/Drug_Master_File‎

   It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States  …

   ‎Description – ‎DMFs in the United States – ‎DMFs in Europe – ‎References

5. Submission requirements for Active Substance Master Files : MHRA

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   Jul 3, 2012 – The following submission guidance is aimed towards the holders of Active Substance Master Files (ASMFs). Since an ASMF is submitted as …

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   http://www.raps.org › Focus Online › News › News – Article View‎

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   Jul 13, 2012 – A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) …

8. Additional Guidance Document on Active Substance Master File

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   GMP News 17/10/2012. Additional Guidance Document on Active Substance Master File (ASMF) published by EMA. The European Medicines Agency (EMA) …

9. GMP Guideline Guideline on Active Substance Master File …

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   Guideline on Active Substance Master File Procedure (CPMP/QWP/ 227/02 Rev. 2). Short Title: CPMP/QWP/ 227/02 Rev. 2. Internet …

Construction of the european drug master file from GlobalCompliancePanel

Six new drugs in clinical development stage: Dr Reddy’s

New Drug Approvals

Hyderabad: Country’s second largest drug maker Dr Reddy’s Laboratories has said it is working on six new drugs in different areas, including metabolic disorders and cardiovascular diseases, psoriasis and migraine.

According to a filing with US Securities Exchange Commission, the drug maker said as of March 31, 2013, DRL had 21 active products in the proprietary products pipeline, of which six are in clinical development stage.

including metabolic disorders and cardiovascular diseases, psoriasis and migraine.

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http://www.deccanchronicle.com/130721/news-businesstech/article/six-new-drugs-clinical-development-stage-dr-reddys

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Cytotoxic activity of the proteins extracted from the leaves of Gynura procumbens

TGI: Thrive Health

Many of the currently available drugs are plant-based, and plant peptides and proteins have turned out to be a critical source of biological compounds that exhibited bioactivities which can be exploited as drugs. They, plant-based products including proteins and small molecular compounds, have been suggested as the favorable drugs for cancer treatment in view of the many adverse effects exerted by current cancer treatments, namely chemotherapy and radiation therapy.

Amongst the activities being discovered were the anti-tumor activity of peptides extracted from

Hypericum perforatum,

Chelidonium majus L.,

Inula helenium L.,

Equiseteum arvense L.,

Inonotus obliquus;

anti-HIV property of macrocyclic peptide extracted from Palicourea condensate,

anti-microbial activity of thaumatin-like proteins extracted from malting barley etc.,

In the current study authors have selected Gynura procumbens (Lour.) Merr. It is a well-known traditional herb in South East Asia. The plant belongs to the Asteraceae Family. This plant is about 10–25 cm high…

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