Could Phase III Clinical Trials be taken without Phase I and II ?

SGquality

Quite Involved in Discussions
#1
My questions is if Phase III Clinical Trials could be undertaken without having the Phase I and II clinical studies done ? The drug under discussion is an already existing product in the market.

Could studies like pharmacokinetics and pharmacodynamics be done as substitute of Phase I and II ?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

Can someone help?

If you had your questions answered in the Cove Forums, please consider helping others.

Thank you very much!
 

Ajit Basrur

Staff member
Admin
#3
My questions is if Phase III Clinical Trials could be undertaken without having the Phase I and II clinical studies done ? The drug under discussion is an already existing product in the market.

Could studies like pharmacokinetics and pharmacodynamics be done as substitute of Phase I and II ?
Yes that approach is acceptable.
 
Thread starter Similar threads Forum Replies Date
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R Class III Medical Device Qualification in Phase 2? Qualification and Validation (including 21 CFR Part 11) 2
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
M What to do in SOP Phase of Head unit testing? IATF 16949 - Automotive Quality Systems Standard 0
S Uncertainty Budgets - Phase Noise (SSB), Harmonics Measurement Uncertainty (MU) 2
K APQP Phase 3 - Team Feasibility Commitment APQP and PPAP 3
R Plan to Volvo Cars for capacity verification in Phase 3 of PPAP Customer and Company Specific Requirements 3
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
A Power Traceability certificate for values for voltage, current and phase General Measurement Device and Calibration Topics 1
K TS 16949 Planning Phase: Raw Materials purchased from Distributer and the PPAP impact IATF 16949 - Automotive Quality Systems Standard 3
V How to Assess Process Capability at the Development or Optimization Phase Capability, Accuracy and Stability - Processes, Machines, etc. 6
V What Ford Phase PPAP Level should DV testing be submitted? APQP and PPAP 1
M Should we analyse risk at the quotation phase or after the order is received? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T Raw Parts Inspections for NPI (New Product Introduction) Phase Supplier Quality Assurance and other Supplier Issues 1
K Task and Sub Tasks of Software Life Cycle Phase Quality Assurance and Compliance Software Tools and Solutions 1
J Project Management - "Quality Check" at each phase of a Project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Comments Required Regarding a Software Requirements Phase Tool Design and Development of Products and Processes 3
G Single Fault Condition for 3-Phase Medical System - IEC 60601 Clause 8.1b IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V Measurement of Robustness of Product at Development Phase Six Sigma 2
M Excel Templates for Plan & Define Phase in NPI Process for Tire Manufacturer Excel .xls Spreadsheet Templates and Tools 1
D Phase 2 Revision to AS 9100 Rev C AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
R How to determine the reference voltage for three-phase transformer? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
C Sub-Supplier compliance to Ford Phase 0 PPAP (Run at Rate) APQP and PPAP 3
V Should Feasibility be done in the APQP phase - TS 16949 Clause 7.2.2.2 IATF 16949 - Automotive Quality Systems Standard 2
K MSA (Measurement System Analysis) on Multi-Phase Measurement System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
A Renault Quality plan - Quality Plan in Development Phase for Renault customer Design and Development of Products and Processes 4
D How to collect customer complaints/dissatisfactions during development phase? Customer Complaints 6
T Quality tasks for each Design Control Phase ISO 13485:2016 - Medical Device Quality Management Systems 4
V 5 Phase Correctice Action examples wanted Quality Tools, Improvement and Analysis 3
Q Phase 2 Audit - OFI for Supplier Performance and Monitoring IATF 16949 - Automotive Quality Systems Standard 3
Q TS 16949 Phase 1 Requirement Question IATF 16949 - Automotive Quality Systems Standard 2
R Change Control Required? Changes during the product gamma phase IATF 16949 - Automotive Quality Systems Standard 3
C Six Sigma Project - Using FMEA in the Analyze Phase Quality Manager and Management Related Issues 6
D How to practically-conduct, post production phase ISO 13485:2016 - Medical Device Quality Management Systems 1
M Phase 7 Procedures for a Managerial Consultation Company Service Industry Specific Topics 7
N Which SDLC (Systems Development Life Cycle) phase does Quality Assurance Participate Capability, Accuracy and Stability - Processes, Machines, etc. 1
S Need help understanding Ford's Phase 0 PPAP APQP and PPAP 1
M Signatures Requirements for Design phase documents Design and Development of Products and Processes 3
S Why historical data & benchmark data is important in APQP planning phase APQP and PPAP 6
B Examples of APQP - Phase 1 & 2 APQP and PPAP 2
D Deming Cycle PDCA - The Check phase clarification, please Quality Tools, Improvement and Analysis 2
P AS 9100 - Initial Phase Audit - Certified with Majors or Minors? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
S Can anyone provide APQP Timing Plan including Phase 5.0 APQP and PPAP 3
K We Passed Our Ts16949 Phase 1 Readiness Review IATF 16949 - Automotive Quality Systems Standard 1
1 Made it through Phase One - Measureables for Management Review - Need list or form Management Review Meetings and related Processes 9
P How do you evaluate customer complaints? Known indicators during utilization phase Customer Complaints 4
A Electronic box (design phase) - 'Acceptable' ppm Design and Development of Products and Processes 8
D Looking for information on Ford 5 Phase Customer and Company Specific Requirements 7

Similar threads

Top Bottom