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

• Catalyst shall also promptly (i) provide BioMarin with any additional information reasonably requested by BioMarin regarding Development of Licensed Products by or on behalf of Catalyst or its Affiliates, and (ii) notify BioMarin upon Catalyst’s initiation of any IND-Enabling Studies, Clinical Trials or Regulatory Filings relating to Licensed Product.

• Following completion of IND-Enabling Studies for a given Joint SAV Program, the Party that conducted such IND-Enabling Studies will promptly prepare and provide the other Party with the SAV IND Data Package for such Joint SAV Program.

• On a Research Program-by-Research Program basis, within [***] following the date on which the complete IND-Enabling Study Reports from the IND-Enabling Studies for at least [***] animal species for such Research Program becomes available to Xxxxxxx, Xxxxxxx will deliver to the JRC such IND-Enabling Study Report for such Research Program (the date of such delivery, the “IND-Enabling Study Completion Date”).

• The participants signed a declaration (Appendix E) confirming that they understood what was expected from them and that they participated of their own free will.

• CEWEFIA should support the community members to fence the demonstration site at Anlo to enable the women to use the place.

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, at a minimum, the pharmacokinetic and toxicology studies required to meet the safety regulations for filing an IND, as well as any additional studies required by a Regulatory Authority or hospital ethics committee as a prerequisite to filing an IND.

IND-Enabling Studies means pharmacokinetic and toxicology studies required to meet the requirements for filing an IND, including without limitation any GLP Toxicology Study.

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 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 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 required to meet the requirements for filing an IND/CTA with a Governmental Authority, including ADME (absorption, distribution, metabolism, and excretion) and GLP toxicology studies, or studies required for the preparation of the CMC (chemistry, manufacturing, and controls) section of such IND, including studies relating to analytical methods and purity analysis, and formulation and manufacturing development studies, all as necessary to obtain the permission of the applicable Governmental Authority to begin human clinical testing.