Clinical Lot definition

Clinical Lot means a Pre-Commercial Lot manufactured for the purpose of conducting human clinical studies.
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Examples of Clinical Lot in a sentence

  • Sanofi shall be responsible for all costs and expenses in connection with the manufacturing and supply of the Licensed Products in the Sanofi Field after the Effective Date, including all Clinical Lot Manufacturing Costs, the cost of qualifying its facilities, and the cost of qualifying a Third Party supplier for manufacture of the Licensed Product in the Sanofi Field, if necessary.

  • The prostate GVAX immunotherapy will consist of 2.5 × 108 cells from the AAV genomic GM-CSF–transduced PC3 Clinical Lot and 1.6 × 108 cells from the AAV genomic GM-CSF–transduced LNCaP Clinical Lot.

  • Prior to delivery to NovaCardia of each Pre-Commercial Lot supplied pursuant to this Agreement, DPC shall send to NovaCardia (a) confirmation in writing that such Pre-Commercial Lot was manufactured in accordance with the applicable Batch Records and (b) if such Pre-Commercial Lot is a Clinical Lot, a Certificate of Analysis with respect to such Clinical Lot (the "Compliance Papers").

  • Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤ 49 Years of Age.For Pfizer Internal Use OnlyNCT05096208; 5.

  • Clinical Lot Production: 40% upon initiation of the clinical production phase; 30% no more than 30 days after project initiation; 30% upon lot release.

  • Dissolution Profiles for Ivosidenib Tablets, 250 mg: Film-Coated, Non- debossed (Clinical Lot TTZV5) Versus Commercial Presentation Film-Coated, Debossed (Lot WNPY) 5 Used in clinical study AG120-C-004 (food effect) and AG120-C-007 (clinical DDI study with itraconazole) Figure 5.

  • Development Phase: To conclude within 90 calendar days of the later of: (i) the Effective Date, (ii) supply of the components (e.g. fibrin) by Metamorefix Clinical Lot: To conclude within 90 days after completion of the Development Phase.

  • PROTOCOL SUMMARY‌‌1.1. SynopsisBrief Title: Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to≤49 Years of Age IndicationPfizer’s RSV stabilized prefusion F subunit vaccine (RSVpreF) is a prophylactic vaccine that is being developed for 2 indications: • Maternal: Prevention of LRTI-RSV in infants by active immunization of pregnant women.• Older Adult: Prevention of RSV-associated msLTRI in adults 60 years of age and older via active immunization.

Related to Clinical Lot

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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 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 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.

  • 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.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • 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 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 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.

  • 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.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • 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 evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • 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.

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

  • 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 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.

  • 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;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • 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 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).