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Anthony Crasto Process Research- Overview

Anthony Crasto Process Research- Overview

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Anthony Crasto Process Research- Overview
Anthony Crasto Process Research- Overview

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Categories:Types, Research
Published by: Anthony Melvin Crasto Ph.D on Feb 07, 2012
Copyright:Attribution Non-commercial

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07/22/2013

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DR ANTHONY M CRASTO (Ph.D)PRINCIPAL SCIENTISTPROCESS RESEARCHDEC 2011³A SHORT PRESENTATION´
 
1.
What is Process Research ?
2.
Its 12 Principles
3.
Definition
4.
Objectives
5.
Personnel requirements
6.
GMP Considerations
7.
Process economics
8.
Industry challenges
9.
Case Studies-Remoxipride and chiral piperazine
10.
Lesson Learned: ³Unlocking the Potential of Process Innovation´
 
Net Cost: $802 MillionInvested Over 15 YearsNet Cost: $802 MillionInvested Over 15 Years
5,000±10,000Screened250Enter PreclinicalTesting5Enter ClinicalTesting1
Compound SuccessRates by StageCompound SuccessRates by Stage
16161414121210108866442200Phase II
100±300 Patient VolunteersUsed to Look for Efficacyand Side Effects
Phase II
100±300 Patient VolunteersUsed to Look for Efficacyand Side Effects
Phase III
1,000±5,000 PatientVolunteers Used to Monitor  Adverse Reactions toLong-Term Use
Phase III
1,000±5,000 PatientVolunteers Used to Monitor  Adverse Reactions toLong-Term Use
FDA Review ApprovalFDA Review ApprovalAdditional Post-Marketing TestingAdditional Post-Marketing TestingPhase I
20±80 Healthy VolunteersUsed to Determine Safetyand Dosage
Phase I
20±80 Healthy VolunteersUsed to Determine Safetyand Dosage
Preclinical Testing
Laboratory and Animal Testing
Preclinical Testing
Laboratory and Animal Testing
Discovery
(2±10 Years)
Discovery
(2±10 Years)
YearsYears
New Product DevelopmentNew Product Development ± ± A Risky and Expensive Proposition A Risky and Expensive PropositionNew Product DevelopmentNew Product Development ± ± A Risky and Expensive Proposition A Risky and Expensive Proposition
Approved bythe FDAApproved bythe FDA

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