By Raymond A. Huml

This short defines aggressive intelligence (CI) as a device for making funding judgements in the pharmaceutical industry.  It presents an outline of methods that the regulatory affairs specialist needs to take into consideration whilst comparing info impacting product-based danger reviews. those practice fairly to reviews that concentrate on outputs resembling regulatory approval, or the economic impression of product labeling at the revenues forecast over a constrained time-frame. The short additionally offers an outline of highbrow estate evaluate which can impression a product’s lifespan out there because of patent safety itself (or lack of patent safety) or through regulatory exclusivity. Case examples are mentioned to demonstrate the importance of maintaining with the ever-changing rules, and how to interpret them within the context of CI. additionally, there's a part on digital facts rooms (VDRs) which at present functionality because the cornerstone of due diligence investigations. whereas aimed basically at regulatory affairs execs within the usa, this ebook presents an invaluable adjunct for different pharmaceutical executives, specially these new to product-based investments, and regulatory affairs execs in different areas. ​

Show description

Read Online or Download Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional (SpringerBriefs in Pharmaceutical Science & Drug Development) PDF

Best pharmacology books

Download e-book for iPad: Combination Products: Regulatory Challenges and Successful by Smita Gopalaswamy,Venky Gopalaswamy

The sector of mix product improvement (products born of the combination of clinical units, biologics, and medication) is so new that, whereas literature abounds on each one half separately, there are only a few guides, together with FDA files, on hand about the precise demanding situations posed via this nascent yet fast-growing zone.

Download PDF by Katja Becker: Apicomplexan Parasites: Molecular Approaches toward Targeted

This instruction manual is the 1st facing the invention of gear directed opposed to apicomplexan parasites. among others, this team of endoparasites contains the causative brokers of Malaria, Toxoplasmosis, and Babesiosis, the latter taking place often in animals. Written via well known medical specialists from academia and undefined, the booklet specializes in currentdrug improvement methods for all apicomplexan illnesses making it beautiful to a wide viewers, starting from learn labs in academia to the human and veterinarian pharmaceutical undefined.

Download e-book for kindle: Assessing Bioavailablility of Drug Delivery Systems: by Jean-Maurice Vergnaud,Iosif-Daniel Rosca

Exploring how you can follow in vitro/in vivo correlations for managed liberate dosage kinds, Bioavailability of Drug supply structures: Mathematical Modeling basically elucidates this advanced phenomena and gives a consultant for the respective mathematical modeling. The publication introduces mathematical modeling tools for calculating the profiles of plasma degrees acquired with managed unlock dosage kinds and offers examples and case experiences to demonstrate the innovations hired.

New PDF release: Global Virology I - Identifying and Investigating Viral

This publication offers trajectories and illustrations of viruses that experience catapulted into the worldwide enviornment (linked to people, animals, and vectors) because of human behaviors lately, in addition to viruses that experience already proven enlargement between people, animals, and vectors quite a few a long time in the past. themes within the present booklet contain: vaccinesenvironmental impactemerging virus transmissionFilovirus (Ebola)hemorrhagic feversflavivirusesDengue evasionpapillomavirusesHepatitis CNipah virusgiant viruseshantavirusesbunyavirusesencephalitidesWest Nile virusZika virusXMRVhenipaviruseshuman respiration syncytial virusinfluenza A virusseveral elements of HIV-1

Additional resources for Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional (SpringerBriefs in Pharmaceutical Science & Drug Development)

Example text

Download PDF sample

Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional (SpringerBriefs in Pharmaceutical Science & Drug Development) by Raymond A. Huml


by Richard
4.2

Rated 4.26 of 5 – based on 27 votes