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Methotrexate
Biosimilars, its development and it's regulatory guidelines.
This presentation, “Phase 0 Trials by Dr. Surya K,” is designed to offer a clear, structured, an...
edit off label use When a drug is used in a way that is different from what is described in the FDA-...
INVESTGATIONAL NEW DRUG APPLICATIONS
Good Laboratory Practices
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Regulatory affairs
Code of Federal Regulations (CFR).CFR is the codification of the general and permanent regulations p...
Details about the qualification and validation in the pharmaceutical analysis. Definitions, types an...
Biosimilars / Follow on Biologics/ Subsequent Entry Biologics
Drug safety evaluation in clinical trial
This New Drug Approval Process The new drug approval process is a complex and rigorous process that...
Q.R are planned and documented by an inspections of a review item The review item may be a product,...
introduction to biosimilar drug difference between biosimilars and generic drugs global scenarios I...
meta analysis and spontaneous reporting of ADR's
ppt on Herbal supplements
This presentation gives knowledge on ICH and its History, Mission, and overview of ICH Quality, Safe...
In these slides you can get the information of clinical trials which have four phase I,II,III, IV. b...
SUPAC respresents the changes recommended by US FDA at the time of scale up or approval of NDA / AND...
it is all about GMO
It consist of batch packaging record details related to regulatory affairs
AERB, IAEA, Dose limits
impurity and stability studies m pharmacy
![cmc [ chemistry manufacturing control ]](https://slidepub.com/thumb/1133/123501133.jpg)
