Test Formulation definition
Examples of Test Formulation in a sentence
PARI shall regularly provide the Project Team with written reports regarding the development of the Test Formulation, Test Drug Product, Test Inhaler, Formulation, Drug Product and Inhaler.
PARI shall use commercially reasonable efforts to develop the Test Formulation in such a manner that it does not consist of or comprise the Undesired Formulations.
PARI shall develop the Test Formulation and Test Drug Product substantially in compliance with its internal quality control and product specification standards or as otherwise agreed upon by PARI and SALUS.
PARI shall develop a Test Formulation and Test Drug Product: (a) in accordance with the Development Plan; (b) substantially in accordance with the Drug Product Specifications; and (c) in accordance with the terms and conditions of Section 3.10 below.
SALUS shall supply PARI with quantities of the Active Ingredient in accordance with the terms and conditions of Section 3.10 below for PARI’s development of the Test Formulation and Test Drug Product.
PARI shall develop the Test Formulation for the Pre-Clinical, Phase I Clinical and Phase II Clinical Studies.
For the Phase I Clinical Study and Phase II Clinical Study: (a) SALUS shall supply PARI with the Active Ingredient at least in substantial compliance with cGMP or ECGMP, whichever is applicable; and (b) PARI shall develop and manufacture the Test Formulation, Test Drug Product and Test Inhaler at least in substantial compliance with cGMP or ECGMP, whichever is applicable.
In accordance with the strategy approved by SALUS, PARI shall manufacture for and deliver to SALUS the Test Formulation and Test Drug Product for examination, testing and comment in the quantities and according to the timeframes set forth in the Development Plan for such Studies.
At SALUS’ request, PARI shall also cooperate with SALUS in its efforts to complete the development of the Test Formulation or Formulation by providing SALUS with technical information related to PARI’s development of the Test Formulation, Formulation, Test Inhaler and Inhaler.