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Clinical Research

Thursday, 20 March 2014. ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). ICH topics are divided in to 4 major types:. Ie, those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.). Ie, those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Https:/ www.ich.org/cache/html/250-272-1.html. ICH - Multidisciplinary Topics.

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Clinical Research | clinicalresearchzone.blogspot.com Reviews

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Thursday, 20 March 2014. ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). ICH topics are divided in to 4 major types:. Ie, those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.). Ie, those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Https:/ www.ich.org/cache/html/250-272-1.html. ICH - Multidisciplinary Topics.

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3 2 safety topics

4 3 efficacy topics

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Clinical Research | clinicalresearchzone.blogspot.com Reviews

https://clinicalresearchzone.blogspot.com

Thursday, 20 March 2014. ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). ICH topics are divided in to 4 major types:. Ie, those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.). Ie, those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Https:/ www.ich.org/cache/html/250-272-1.html. ICH - Multidisciplinary Topics.

INTERNAL PAGES

clinicalresearchzone.blogspot.com

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Clinical Research

http://clinicalresearchzone.blogspot.com/2014/03/sources-of-icsr-unsolicited-sources.html

Wednesday, 5 March 2014. Sources of ICSR: Unsolicited Sources. Consumer adverse reaction reports should be handled as spontaneous reports irrespective of any subsequent "medical confirmation", a process required by some authorities for reportability. Even if reports received from consumers do not qualify for regulatory reporting, the cases should be retained. Emphasis should be placed on the quality of the report and not on its source. Labels: Sources of ICSR: Unsolicited Sources. Common Terminology Crit...

2

Clinical Research

http://clinicalresearchzone.blogspot.com/2014/03/ich-multidisciplinary-topics.html

Thursday, 20 March 2014. ICH - Multidisciplinary Topics. Topics are categorized in to five types:. ICH M1: MedDRA(Medical Dictionary). ICH M2: ESTRI(Electronic Standards for the Transfer of Regulatory Information). ICH M3: Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals. ICH M4: CTD(Common Technical Document). ICH M5: Data Elements and Standards for Drug Dictionaries. Http:/ www.ich.org/UrlGrpServer.jser? View my complete profile. Simple...

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Clinical Research

http://clinicalresearchzone.blogspot.com/2014/03/how-to-monitor-new-medicines-and.html

Thursday, 6 March 2014. How to Monitor new medicines and vaccines- MHRA. New chemicals and vaccines are effectively put on probation for up to two years and labelled with a black triangle to ensure prescribers are aware of the need to monitor them carefully. The black triangle symbol. Labels: How to Monitor new medicines and vaccines- MHRA. Subscribe to: Post Comments (Atom). ICH(International Conference on Harmonisation ofTe. ICH - Multidisciplinary Topics Multidisciplinary . Difference between Protoco...

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Clinical Research

http://clinicalresearchzone.blogspot.com/2014/03/pharmacovigilance-software-emea-or.html

Wednesday, 5 March 2014. The EMEA or the European Medicines Agency in Europe develops and maintains the pharmacovigilance database of probable serious adverse effect medicines in the market. This system is called EudraVigilance. Kinds of pharmacovigilance software:. PV Works (Vet) is another software system made to support veterinary pharmacovigilance business and technical processes meeting the necessary safety standards. Data entry, reporting, audit trail are some of its main features. The outsourced p...

5

Clinical Research

http://clinicalresearchzone.blogspot.com/2014/03/product-monograph-product-monograph.html

Thursday, 6 March 2014. Product Monograph should have the information which can communicate with the sections described below:. This particular area covers essential prescribing information, including dosage and strength, indications and clinical uses, warnings and precautions, adverse reactions and drug interactions. Such a section may or may not be included. It is informative about how to use the medicine safely and most effectively. Contents of a product monograph:. 1 Pharmacology of the drug. How to ...

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Clinical Research

Thursday, 20 March 2014. ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). ICH topics are divided in to 4 major types:. Ie, those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.). Ie, those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Https:/ www.ich.org/cache/html/250-272-1.html. ICH - Multidisciplinary Topics.

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