Page 89 - Health Impact Assessment of policies related to local pharmaceutical industry development towards technology readiness and access to medicines: HIAPP

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แหล่งที่มา

Straub, 2015 Mitchell, 2006 Medtech4Health, 2012 Richard, 2018
ล าดับ
(NASA) (Sandia (Pharmaceuticals) (Medical

National Lab) Science)

assays. Continued development of
animal models for efficacy and

dose-ranging studies. Selection of

candidate drug. GLP safety studies
for IND submission and Phase 1

6. System/sub- Representative Clinical development. GMP

system of the production, IND submission and
model or deliverable Phase I clinical evaluation

prototype demonstrated performed proceeding to Phase II.
Phase I Trials
demonstration in in relevant Appropriate safety evaluations
an environment conducted to support further

operational development

environment
7. System prototype Key final Phase II clinical study is completed.

demonstration in development Manufacturing process scale-up and

an version of the process validation initiated and
operational deliverable stability testing ongoing. Continued

environment. demonstrated safety studies to support further Phase II Trials

in operational clinical testing. The TPP refined
environment when necessary. Phase III clinical

plans defined and approved by

regulatory authorities.
8. Actual system Actual Manufacturing processes validated.

completed and deliverable Pivotal clinical Phase III testing and

"flight qualified" qualified safety studies completed. NDA or
through test and through test BLA prepared and submitted. Phase III Trials

demonstration. and Approved by appropriate regulatory

demonstration authorities.