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Biosimilars
This ppt gives one an idea about important topics,units,questions,books for Industrial Pharmacy
a
CSV
Please review the material to gain a better understanding of the basics of Good Laboratory Practices...
GLP and GMP
Objectives of quality control
COMMON TECHNICAL DOCUMENT
New drug application submitted by the manufacture of a drug to the FDA-after clinical trials have b...
Regulatory reporting is a fundamental aspect of scientific research and is crucial for ensuring comp...
It is overview of preclinical and clinical development consideration for herbals and biologics in US...
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market. B. Pharm. Final Year, Sem-V...
Topics: REGULATORY REQUIREMENT FOR APPROVAL OF API, BIOLOGICS, NOVEL DRUGS AND NDA Prepared B...
Regulatory perspective of clinical trials, phases of clinical trials,ICH-GCP Principles
regulatory affairs
ICH guidelines History of ICH guidelines Members of ICH guidelines
validation on lifecycle approach as per as the USFDA
terapia antiemetica
CLSI 2021
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Gui...
This topic contains content suitable for Mpharm pharmaceutics syllabus.
An in-depth analysis of the tissue-extraction technique of morcellation, used in gynaecological surg...
basic guidlines of packaging of pharmaceuticals
