Page 88 - Health Impact Assessment of policies related to local pharmaceutical industry development towards technology readiness and access to medicines: HIAPP

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

แหล่งที่มา

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

National Lab) Science)

of concept. approaches and early proof of
concept in a limited number of in

vitro & in vivo models.

4. Component Key elements Preclinical R&D. Optimization of
and/or demonstrated candidates and in vivo

breadboard in laboratory demonstration of activity and

validation in environment efficacy. Identification and
laboratory integration of critical technologies

environment. (animal models, biomarkers, assays,

etc.) in continued characterization of
and development of potential

candidates. Initiation of GMP process

development and manufacturing of
non-GMP material and drug

formulations. Evaluation of safety,

pharmacodynamics and
pharmacokinetic properties.

Formulation of a Target Product

Profile initiated.
5. Component Key elements Further characterization of

and/or demonstrated candidate, i.e. absorption,

breadboard in relevant distribution, metabolism and
validation in environment elimination. A manufacturing

relevant process established amenable to Late Preclinica
l Research
environment. large scale GMP manufacturing and
consistent with the intended use of

the drug. Development of in process

controls and relevant analytical