TY - JOUR
T1 - Good laboratory practices
T2 - Need of the hour
AU - Ravi, G. S.
AU - Dubey, Akhilesh
AU - Shetty, Kavya
AU - Hebbar, Srinivas
AU - Sandeep, D. S.
AU - Charyulu, R. Narayana
N1 - Publisher Copyright:
© 2019, Indian Pharmaceutical Association. All rights reserved.
PY - 2019/8
Y1 - 2019/8
N2 - Good Laboratory Practice is a set of guidelines to regulate the non-clinical research laboratories involved in the testing of articles to assess their safety under laboratory conditions, which is defined as per Organization for Economic Co-operation and Development principles. It is the quality management system of non-clinical studies encourages the researchers to conduct the laboratory studies with the validated, standard methods that yield a quality and validity for the test data. It assures that the submitted data to the regulatory authorities is based on the real study carried out in the laboratory and it is a true reflection of the results obtained, hence it can be relied upon while making the safety/risk assessments. The GLP study data is important in the risk assessments related to the users, consumers, including the environment in variety of the fields such as industrial and agro chemicals, pharmaceuticals, veterinary medicines, cosmetics, biocides, feed additives etc.The GLP compliance is an assurance of reporting the safety data to the regulatory bodies and its main aim is to provide a high-quality new drug to the market.
AB - Good Laboratory Practice is a set of guidelines to regulate the non-clinical research laboratories involved in the testing of articles to assess their safety under laboratory conditions, which is defined as per Organization for Economic Co-operation and Development principles. It is the quality management system of non-clinical studies encourages the researchers to conduct the laboratory studies with the validated, standard methods that yield a quality and validity for the test data. It assures that the submitted data to the regulatory authorities is based on the real study carried out in the laboratory and it is a true reflection of the results obtained, hence it can be relied upon while making the safety/risk assessments. The GLP study data is important in the risk assessments related to the users, consumers, including the environment in variety of the fields such as industrial and agro chemicals, pharmaceuticals, veterinary medicines, cosmetics, biocides, feed additives etc.The GLP compliance is an assurance of reporting the safety data to the regulatory bodies and its main aim is to provide a high-quality new drug to the market.
UR - https://www.scopus.com/pages/publications/85079445763
UR - https://www.scopus.com/inward/citedby.url?scp=85079445763&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:85079445763
SN - 0031-6849
VL - 51
SP - 9
EP - 11
JO - Pharma Times
JF - Pharma Times
IS - 8
ER -