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The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, comm...
drug regulatory affaris
WTO
Regulatory affairs
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PR...
Safety Monitoring in Clinical Trails, Safety Proicedures to be Fallowed
The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clin...
Globalization for development,_meeting new challenges by Ian Goldin and Kenneth Reinet Chapter 1
Detailed constitution and functions of IRB
“CSR is a detailed regulatory document which gives the information about the methods and results (...
INFORMED CONCENT PROCESS AND PROCEDURE IN CLINICAL TRIALS
ICH GUIDELINE .M.PHARM , B.PHARM REGULATORY AFFAIRS
Randomization is the process by which allocation of subjects to treatment groups is done by chance, ...
COMMON TECHNICAL DOCUMENT
A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPL...
Safety pharmacology are Studies that investigate the potential undesirable pharmacodynamic effects o...
Verifikasi metode uji di lab lingkungan
ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM) - Contents - ICH - ICH GUIDELINES - Objective Q1...
GCP is a set of guidelines for how clinical trials should be carried out. It ensures that the data...
Pharmacovigilance is the science and activities related to the detection, assessment, understanding,...
Special emphasis on Q series guidelines
A brief introduction to Drug Regulatory Affairs and Its Regulatory Authority.
intro, scope, merits, ich, who guidelines
QUALITY BY DESIGN OF PRODUCT DEVELOPEMENT
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