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framus_morrigan

Re: Farmas USA

Actualizare y ordenare este contenido a medida que localice info relevante.

------ BIBLIOTECA FARMAS -----

Clinical Development Success Rates ( nuevo )

https://www.rankia.com/foros/bolsa/respuestas/3313863-clinical-development-success-rates-drugs-phase-sucess-incluye

Risk in Vaccine Research and Development Quantified ( nuevo )

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057755

Can Corporate Officers Sell Stock? - Signaling from CEO Stock Sales  ( nuevo )

http://www.semlerbrossy.com/wp-content/uploads/ATD-Can-Officers-Sell-Stock.pdf

Continued Listing Standards for Nasdaq    ( nuevo )

https://listingcenter.nasdaq.com/assets/continuedguide.pdf

Inversión en biotecnologia 2005-2014

http://www.bio.org/sites/default/files/BIO%20Emerging%20Therapeutic%20Company%20Report%20June%2011%202015.pdf

Tocho-Glosario de Términos de Ensayos Clínicos ( nuevo )

http://www.tremedica.org/panacea/IndiceGeneral/n27_tradyterm-saladrigasetal.pdf ( parte 1 )

http://www.tremedica.org/panacea/IndiceGeneral/n28_tradyterm-saladrigasycleo.pdf ( parte 2 )

Términos de Ensayos Clínicos ( nuevo ) 

http://www.imim.cat/media/upload/arxius/terminologia.pdf

Pharmaceuticals: From Development to Commercialization

https://www.rankia.com/foros/bolsa/respuestas/2879615-pharmaceuticals-from-development-to-commercialization

Proceso de Aprobacion de Farmacos :

  http://www.mdclinical.org/espanol/drug-approval-process.php

Desarrollo, pruebas y reglamentos para las vacunas : 

http://www.historyofvaccines.org/es/contenido/articulos/desarrollo-pruebas-y-reglamentos-para-las-vacunas

Clinical Trials - Phases : 

http://www.uchc.edu/patients/clinical_trials/pdfs/phases.pdf

Overview of a drug develpment - by Novartis : 

http://www.ich.org/fileadmin/Public_Web_Site/Training/GCG_-_Endorsed_Training_Events/APEC_LSIF_FDA_prelim_workshop_Bangkok__Thailand_Mar_08/Day_1/Clinical_Dev_Plans_-_Namrata_Bahadur.pdf

Endpoints: How the Results of Clinical Trials are Measured : 

http://cancerguide.org/endpoints.html#response

Steve's Strategic Guide to the Clinical Trial System :

http://cancerguide.org/clinical_trials.html

 

The FDA's Drug Review Process 

http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm295473.htm (Infografia)

Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review: 

http://www.fda.gov/ForPatients/Approvals/Fast/default.htm

FDA Fast-Track Drug Approval Program: 

http://www.drugwatch.com/2012/01/18/fda-fast-track-drug-approval-program/

Fast Tracks & Expedited Programs - Guide for Industry: 

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

NME y NCE: 

http://www.clinuvel.com/en/pharmaceutical-development/new-molecular-entity

Special Protocol Assesment - Guide for Industry: 

http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf

A Food Labeling Guide - Guide for Industry:

  http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf

Formal meetings between FDA and Sponsor or Applicants: 

http://www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf

Acta de Hatch-Waxman: Aprobado por el Congreso para legislar las disputas y conflictos por patentes.: 

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm119225.pdf

FDA Updates PDUFA Goals: NDA’s, BLA’s and REMS: 

http://www.policymed.com/2013/01/fda-updates-pdufa-goals-ndas-blas-and-rems.html

PDUFA V - Guides: 

http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/R42366_02222013.pdf

http://www.topra.org/sites/default/files/regrapart/1/4665/topra_regrapp_nov2012_beakes-read.pdf

Copayment Tier Definitions:

https://www.bcbsnc.com/content/services/formulary/rxdef.htm

 

Putting a price on biotechnology :  http://www.recourtls.nl/index_bestanden/mcbb/pricing_biotechnology.pdf

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