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The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of IC...
introduction to biosimilar drug difference between biosimilars and generic drugs global scenarios I...
It is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss...
Biosimilars
M. Pharm. Pharmaceutics First Year First Semester
Basic information for beginners...
MedDRA is a terminology used in pharmacovigilance which is used in coding the different aspects in c...
Code of Federal Regulations (CFR).CFR is the codification of the general and permanent regulations p...
brief history of GMP
Good laboratory practice (GLP)
Documentation in Pharmaceutical Industry - master formula record , DMF ( DRUG MASTER FILE )
good
1) Introduction 2) ICH Q8 guidline 3)Regulatory and Industry views on QbD 4)Scientifically Based Qb...
Out of specification PPT as per practicle approach and reference review with guidelines
Good clinical practices-drug discovery
The Common Technical Document (CTD) is a standardized format for regulatory submission of informatio...
ICH GUIDELINE :Q3C
Ptsm
- Whilst the realization of the CTD took many years, there is now a common format for the submission...
Good Laboratory Practices
ICH GUIDELINES Q8, QbD