IND-Enabling Studies definition
IND-Enabling Studies means the pharmacokinetic and toxicology studies required to meet the regulations for filing an IND.
IND-Enabling Studies means studies which are specifically required for an IND, including without limitation, ADME and GLP toxicology studies, or studies required for the preparation of the CMC section of an IND including studies relating to analytical methods and purity analysis, and formulation and manufacturing development studies, all as necessary to obtain the permission of regulatory authorities to begin human clinical testing.
IND-Enabling Studies means studies that are specifically required for an IND, including ADME (absorption, distribution, metabolism, and excretion), GLP toxicology studies, or studies required for the preparation of the CMC section of an IND, including studies related to analytical methods and purity analysis, and formulation and manufacturing development studies, all as necessary to obtain the permission of Regulatory Authorities to begin human clinical investigations.
Examples of IND-Enabling Studies in a sentence
In addition, where such Candidate Compound does not meet such Immunology DC Criteria but Licensor decides to designate such Candidate Compound as a development candidate and advance such Candidate Compound to IND-Enabling Studies, Licensor will, prior to such JRC meeting, [***] provide Novartis with a written explanation setting forth its reasons for such decision in reasonable detail for discussion at such JRC meeting, which outcome of such discussions will be reflected in the minutes of such meeting.
If Development Candidate Designation does not occur prior to the end of the [***] Research Plan Duration, then the Parties will discuss in good faith the additional Research activities necessary to progress a Licensed Compound to IND-Enabling Studies and agree upon a work plan for such activities, which Research activities would be added to the [***] Research Plan as an amendment thereto.
More Definitions of IND-Enabling Studies
IND-Enabling Studies means studies performed specifically for inclusion in an IND, including without limitation ADME and GLP toxicology, as well as formulation and manufacturing development necessary to obtain the permission of regulatory authorities to begin human clinical testing.
IND-Enabling Studies means studies which in each case are reasonably necessary to obtain approval of an IND, including GLP, ADME (absorption, distribution, metabolism and excretion), toxicology, pharmacology and safety pharmacology studies, or studies of chemistry, manufacturing and controls.
IND-Enabling Studies means studies that are reasonably required to meet the requirements for filing an IND with a Regulatory Authority, including GLP toxicology and safety studies, or studies required for the preparation of the CMC section of such IND, including studies relating to analytical methods and purity analysis, and formulation and manufacturing development studies, and which also includes ADME (absorption, distribution, metabolism, and excretion) information, all as necessary to obtain the permission of the Regulatory Authority in the relevant jurisdiction to begin human clinical testing, which, for the avoidance of doubt, include the studies and activities identified in each of the HBV Research Plan or the HIV Research Plan as IND-Enabling Studies.
IND-Enabling Studies means the genotoxicity, acute toxicology, safety, pharmacology, and/or sub-chronic toxicology studies in species using applicable GLPs that in Merck’s sole discretion satisfy applicable regulatory requirements and meet the standard necessary for submission as part of an IND filing with a Regulatory Authority.
IND-Enabling Studies means, with respect to Antibodies, Compounds or Therapeutic Products, toxicity studies evaluating such Antibodies, Compounds or Therapeutic Products that are conducted in accordance with GLP.
IND-Enabling Studies means, for a given SAV Program, the non-clinical pharmacology studies (including pharmacokinetic and toxicology studies) identified in the POC Plan for such SAV Program that are intended to be performed prior to filing an IND/CTA with respect to the SAVs that are being Researched for such SAV Program under the POC Plan.
IND-Enabling Studies means, in respect of a Development Candidate, any and all studies that may be required for filing an IND with a Regulatory Authority, including ADME (absorption, distribution, metabolism, and excretion) studies and GLP (good laboratory practice) toxicology studies, or studies required for the preparation of the CMC (chemistry, manufacturing, and controls) section of such IND, including but not limited to studies relating to analytical methods and purity analysis, and formulation and Manufacturing development studies, all as necessary to obtain the permission of the Regulatory Authority in order to initiate first in human Clinical Trials for such Development Candidate.