ICH Guidelines!!

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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use which we simply refer as ICH is a distinct in getting together the various "regulatory authorities and pharmaceutical industry" of Japan, Europe and US to discuss about various scientific and technical requirements of drug registration. In general ICH topic is divided into 4 major categories. 1. Quality 2. Safety 3. Efficacy 4. Multidisciplinary Quality guidelines: These include * Stability studies * Analytical Validation * Specifications * GMP risk management * Quality risk management * Impurity profile etc Safety guidelines: These include * Carcinogenicity studies * Genotoxicity studies * Toxicokinetics and Pharmacokinetics * Reproductive Toxicity * Immunotoxicology studies * Non clinical evaluation for Anticancer pharmaceuticals * Photosafety evaluation etc Efficacy guidelines: These include * Clinical safety * Dose response studies * Ethnic factors * Good clinical practice * Clinical trials * Clinical evaluation * Pharmacogenomics etc Multidisciplinary: These include * Common Technical Document (CTD) * Non clinical safety studies * Gene therapy * Genotoxic impurities * MedDRA Terminology THIS BLOG IS FREE OF PLAGIARISM Ref: http://www.ich.org/products/guidelines.html accessed on Nov 30th 2011.
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About the Author

Sirisha Pingali's picture
Author: Sirisha Pingali

Comments

Ranjit Kumar Patchala's picture

Dear sirisha, can you please elobrate on Impurity profile. also can you present a detail note on how to fix impurity profile/Limits for new chemical entity. With Regards, Ranjit Kumar.P, Medreich limited, Bangalore.

Ranjit kumar P

Sravani kompella's picture

ICH Q3AR gives entire information regarding impurity profile....This link gives u the information. http://www.ikev.org/haber/stabilite/kitap/37%201.9%20%20Stability%20Work... referred on december 02,2011.
Ranjit Kumar Patchala's picture

Thanks for the valuable information. With Regards, Ranjit Kumar.P

Ranjit kumar P

Siva Mavuduru's picture

nice elucidated good work dear
Sirisha Pingali's picture

dear siva, thank you for the valuable comment!

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

Siriki Praveen Kumar's picture

simple and clear blog....

Regards,

S. Praveen Kumar.

sirikipraveen11@gmail.com

Pharma warriors

Sirisha Pingali's picture

thank you for the valuable comment praveen!

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

Sandhya Sravya malla's picture

good blog !!! your blog reminded me the MYBO quiz and i think it was one of the question and you have answered it right????? anyways good and inportant one good luck m.sandhyasravya@gmail.com
Sirisha Pingali's picture

hi sandhya thank you for the valuable comment! Well, i am in the intense mood of answering this query so with no prior thinking i grabbed the mike (:

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

Siva Mavuduru's picture

Hi dear I am enjoying your presence at mybo felt glad when you waited for me to share the chocolate
Sirisha Pingali's picture

I think we are the persons who is expecting mike to yell the answer. Remember we missed Sumatriptan and Venkateswarlu answer?? Finally through ICH i made it (:

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

Satyajeeth Pandey's picture

Sirisha You did a good work on this platform after this competition also keep updating your knowledge with journals and websites. this is a good website and make best use of it My good wishes to you

Satyajit Panda Asst. professor Maharajah's College Of Pharmacy

Sirisha Pingali's picture

Sir, Thank you very much for the valuable comment. Sure sir, I'll try to cope up with the boosting investigations in the near future too. I consider this competition as a boon to me since this site has opened many corners in my profession. Working with a dedicated person like you made the competition more interesting.

Sirisha Pingali

http://www.pharmainfo.net/sirisha

Viswanadha Institute of Pharmaceutical Sciences.

www.vnips.edu.in

Amar Patil's picture

this pptn is very nice mam

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