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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 09:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 09:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 01:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-20 19:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-18 23:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-18 22:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 07:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-04 20:52:16
CONSORT III (2010)   by  on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 12:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by  on 2010-01-27 11:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by  on 2010-01-22 10:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by  on 2010-01-21 11:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by  on 2010-01-13 20:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by  on 2010-01-12 12:15:13
PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Cancer   by  on 2010-01-10 20:23:31
PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS   by  on 2010-01-10 20:00:18
EMEA Guidelines on Cystic Fibrosis Drug Development   by  on 2010-01-05 09:14:16
US-FDA' proposed rule on Informed Consent regulations   by  on 2010-01-02 22:22:47
US FDA Warning Letters in Clinical Investigation for the Month of December 2009   by  on 2009-12-31 09:10:00
International Compilation of Human Research Protections 2010 Edition   by  on 2009-12-23 14:59:39
ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials   by  on 2009-12-17 20:11:05
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by  on 2009-12-17 19:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by  on 2009-12-04 18:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by  on 2009-11-30 10:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by  on 2009-11-21 07:57:50
Companies to Disclose All Clinical Trials in Patients   by  on 2009-11-19 09:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by  on 2009-11-09 09:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by  on 2009-11-08 22:28:30
PhRMA's New Clinical Trial Guidelines   by  on 2009-10-05 10:21:30
 Subject :Effectiveness of Chiropractic Care.. 2012-03-16 00:43:41 
William Jimenez
Newbie
Joined: 2012-03-16 00:32:51
Posts: 1
Location: 
  • 4294967294
Forum : Anything and Everything
Topic : Effectiveness of Chiropractic Care

“Landmark Studies on the effectiveness of chiropractic”.

 

§  Australian research shows it helps low back pain.

§   New Zealand inquiry proves its incredible safety record.

§  Danish study shows it cures colic in over 90% of cases.

§  Canadian Government study proves it is cost effective.

§  American Government study highly endorses it.

§  British study proves its results are long lasting.

§  West German study reveals it helps headaches.
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 Subject :Cancer Theranostics - Potential Applications of Cancer Biomarker Datab.. 2012-01-16 12:45:14 
Tonny Johnson
Newbie
Joined: 2010-11-10 00:23:48
Posts: 6
Location: 
  • 4294967166
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Cancer Theranostics - Potential Applications of Cancer Biomarker Database

Subject :Cancer Theranostics - Potential Applications of Cancer Biomarker Database

This blog analyzes the potential applications of biomarkers in cancer theranostics (Rx/Dx), a diagnostic therapy process that leads to the development of successful personalized medicine strategies in cancer treatment. Please follow this ink to read this blog: http://tinyurl.com/7f6s2y9
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 Subject :Cell Based Reporter Assays vs. Animal Studies in Drug Discovery .. 2012-01-16 12:43:43 
Tonny Johnson
Newbie
Joined: 2010-11-10 00:23:48
Posts: 6
Location: 
  • 4294967166
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Cell Based Reporter Assays vs. Animal Studies in Drug Discovery

Cell Based Reporter Assays vs. Animal Studies in Drug Discovery- Potential Limitations, Risks and Liabilities

This blog critically analyzes the potential scientific limitations, risks and liabilities of cell based reporter assays, including non-natural protein based reporter assays (e.g. circularly permuted firefly luciferase or GFP based reporter assays) and stem cell based assays, in drug discovery and development.  Scientific arguments have been put forward to suggest that current format of cell based reporter assays may not be ideal for replacing animal studies. This blog also analyzes the potential negative impact of patents and intellectual property (IP) rights in fostering innovations in cell based assays. Finally, this blog warrants imposing accountability, tighter regulations and demanding higher standards in cell based assays that are used in drug discovery and development. Please follow this link to read the full blog article: http://sciclips.wordpress.com/2012/01/16/cell-based-reporter-assays-vs-animal-studies-in-drug-discovery-potential-limitations-risks-and-liabilities/

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 Subject :Re:Managing Clinical Trials.. 2011-12-26 17:18:25 
Dino Brand
Newbie
Joined: 2011-12-26 16:55:52
Posts: 1
Location: 
Forum : Clinical Operations
Topic : Managing Clinical Trials

Trial managers should be involved early on in the trial design phase, but this is rarely possible because of funding constraints.
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Last Edited On: 2011-12-26 17:18:25 By Dino Brand for the Reason
Low T
 Subject :Re:Argentina: ANMAT - new regulatory update.. 2011-12-13 10:43:39 
William Cron
Newbie
Joined: 2011-12-13 10:33:10
Posts: 1
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Argentina: ANMAT - new regulatory update

Regulatory issues results due to error on behalf of the accused and the resources mentioned above helped in sorting them.

 

VPN mobile

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Last Edited On: 2011-12-13 10:43:39 By William Cron for the Reason
 Subject :Re:Argentina: ANMAT - new regulatory update.. 2011-10-28 15:27:30 
Vishnu
Newbie
Joined: 2011-10-28 15:10:37
Posts: 1
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Argentina: ANMAT - new regulatory update

The resource is very useful for regulatory issues
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 Subject :Diagnostic and prognostic biomarker database launched.. 2011-03-24 20:12:55 
Tonny Johnson
Newbie
Joined: 2010-11-10 00:23:48
Posts: 6
Location: 
  • 4294967166
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Diagnostic and prognostic biomarker database launched

We have launched a unique biomarker database that contains more than 29,000 unique biomarkers (for more than 1800 human diseases), which are manually extracted from patent publications and PubMed abstracts.  This database contains biomarkers of diverse nature such as:
1) Drug efficacy/response biomarkers (7708 unique biomarkers)
2) Disease risk assessment and predictive biomarkers (10,375 unique biomarkers)
3) Protein/peptide/antibody biomarkers (7279 unique biomarkers)
4) Molecular diagnostic biomarkers, including gene/gene expression biomarkers, polymporphisms/SNP biomarkers (including linkage disequilibrium biomarkers) (7206 unique biomarkers)
5) Metabolomic biomarkers (811 unique biomarkers)
6) MicroRNA (miRNA) biomarkers (935 unique biomarkers)
7) Epigenetic biomarkers (700 unique biomarkers)

Please follow this link to access our database: http://www.sciclips.com/sciclips/diagnostic-biomarker-prognostic-biomarker-db.do 
 
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 Subject :Are stem cells ready as a next generation drug discovery tool?.. 2010-12-17 07:47:48 
Tonny Johnson
Newbie
Joined: 2010-11-10 00:23:48
Posts: 6
Location: 
  • 4294967166
Forum : Drug Discovery
Topic : Are stem cells ready as a next generation drug discovery tool?

This Wordpress blog analyzes possible limitations of stem cell derived products in drug discovery research and development. We also argue for the need to create a regulatory system for drug screening assays. Link: http://tinyurl.com/2c8uo78

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 Subject :Visualisation of trials, sites & patient recruitment, 2005-09.. 2010-12-07 09:13:57 
Leon
Newbie
Joined: 2009-07-13 19:19:42
Posts: 23
Location: 
Forum : Clinical Operations
Topic : Visualisation of trials, sites & patient recruitment, 2005-09

Dear Friends,

Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country. Globalisation of clinical trials prompted the European Medicines Agency (EMA) to collect data about where pivotal studies included in marketing authorisation applications (MAA) were performed. This data was published in an EMA report and collated by Outsourcing-Pharma .

Click here to see this visualization.

Kind regards,
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