Preclinical Studies definition

Preclinical Studies means, with respect to a Product, one or more of the following: (i) synthesis and formulation; (ii) physical and chemical properties, (iii) in vitro activity, (iv) in vivo activity in animals, (v) metabolism, absorption and pharmacokinetics data from animal studies, (vi) toxicology data, and (vii) similar studies that are typically performed before first administration of a Product to humans.
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Preclinical Studies means Preclinical Development activities undertaken by or on behalf of Five Prime solely for the purpose of (a) evaluating or assessing the feasibility or desirability of pursuing, or scientific rationale for, a potential Five Prime Independent Development Path or (b) provide the basis of, or additional support for, a Five Prime Independent Development Path.
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Preclinical Studies means studies performed in the drug development process of a lead compound or biological product not involving the introduction of a subject compound or biological product into humans (e.g., the dosing of a human patient in clinical trials). Without limiting the generality of the foregoing, preclinical studies consist of: the selection, evaluation and qualification of putative drugs and/or biological products for therapeutic uses; and pharmacokinetic and pharmacodynamic studies of the pharmacological effects and mechanism(s) of action of the drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known, and, for purposes of certainty include animal studies occurring after first-in-man administration. Preclinical studies specifically exclude any and all toxicology testing, whether in vitro or in vivo.
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Examples of Preclinical Studies in a sentence

  • The Associate Director of Pre-clinical Studies [Health & Welfare] is available to support medical students with welfare issues and provide advice.

  • In addition, include a Preclinical Studies Summary Table (see Sample C) of all relevant preclinical (and where available, clinical) efficacy and safety studies carried out with the Development Candidate (in vitro and in vivo) and summarize major outcomes and findings.

  • ETR exhibits potent in vitro anti-HIV activity against wild type and against HIV isolates with NNRTI resistance mutations such as K103N, Y181C and Y188L (9) (10).1.22 Preclinical Studies Preclinical studies noted EC50 values for wild-type laboratory and primary HIV-1 isolates of 0.9 to5.5 nM (0.4 to 2.4 ng/mL) with little or no loss of activity against HIV-1 variants with the most common NNRTI-related mutations.

  • Coleman CN, Higgins GS, Brown JM, Baumann M, Kirsch DG, Willers H, et al., Improving the584 Predictive Value of Preclinical Studies in Support of Radiotherapy Clinical Trials.

  • Preclinical Studies Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy.

  • VandenDriessche, and M.K. Chuah, Transposons: Moving Forward from Preclinical Studies to Clinical Trials.

  • Pre-clinical Studies: The results of relevant pre-clinical pharmacology, toxicology, pharmacokinetic and IP metabolism studies must be provided in summary form which should address the methodology used, the results and a discussion of the relevance of the findings to the investigated therapeutic (and possible unfavourable or unintended) effects in humans.

  • Further Confidence : Preclinical Studies Confirming Reduction in Polyp Count and High-Grade Dysplasia APC, adenomatosis polyposis coli; ERK, extracellular signal-regulated kinase; FAP, familial adenomatous polyposis.

  • The Parties shall use reasonable efforts to complete the Initial Preclinical Studies within [ * ] after the Effective Date, or such other period as is necessary for their completion and mutually agreed to by the Parties in writing.

  • Macleod, Preclinical Studies of Human Diseases: Time to Take Methodological Quality Seriously, 51 J.


More Definitions of Preclinical Studies

Preclinical Studies means any preclinical pharmacokinetic, toxicology or other study relating to one or more Licensed Products.
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Preclinical Studies means in vitro and in vivo studies of a Product, not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of a Product and whether such Product has a desired effect.
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Preclinical Studies means those certain Preclinical Development studies in the Field, set forth in the Development Plans established in accordance with Article 4 below.
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Preclinical Studies means any non-human studies aiming at determining notably pharmacokinetic, ADME, local tolerability, toxicity and efficacy of the Licensed Product for the purpose of IND filing; "[***]Net Sales Report" means a Sales Report for a Calendar [***]; [***][***] “Regulatory Approval” means, with respect to any Licensed Product, the registrations, authorizations, clearances and approvals of the applicable Regulatory Authority or other Governmental Authority in such country or regulatory jurisdiction (including the FDA, EMA or any notified body) that are necessary to market, sell or otherwise Commercialize such Licensed Product in any country of the Territory (such as a marketing authorization or CE Mark); “Regulatory Authority” means any national, supra national, regional, state or local regulatory authority, department, bureau, commission, council or other Governmental Authority (including the FDA, EMA or any notified body) that is responsible for overseeing the Development, use, Manufacture, transport, storage or Commercialization of the Licensed Product; “Regulatory Filings” means any application for Regulatory Approval, and any notification or other submission made to or with a Regulatory Authority that is necessary or reasonably desirable to Develop (including to conduct Clinical Trials), use, Manufacture, transport, store or Commercialize a particular product for the treatment of human diseases and conditions in a particular country or regulatory jurisdiction, whether made before or after receipt of Regulatory Approval in the country or regulatory jurisdiction. The term “Regulatory Filings” shall include all amendments and supplements to any of the foregoing and all proposed labels, labelling, package inserts, monographs and packaging for a Licensed Product in a particular country; “Reimbursement Approval” means with respect to a particular Licensed Product and a particular country or regulatory jurisdiction, any pricing and reimbursement approvals of the applicable Regulatory Authority, insurance providers or other Governmental Authority in such country or regulatory jurisdiction that are necessary for a sale or transfer of the Licensed Product to any applicable Regulatory Authority or other Governmental Authority, or for a sale or transfer of the Licensed Product to be reimbursable or credited by, charged to or otherwise paid for by, in whole or in part, any applicable Regulatory Authority or other Government Authority in such country or regulatory jurisdi...
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Related to Preclinical Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.