In Studies Clause Samples

The "In Studies" clause defines the terms and conditions under which certain activities, data, or materials are used or referenced within the context of research studies. Typically, this clause outlines the scope of permitted use, such as allowing access to data or materials solely for the purposes of conducting specified studies, and may set requirements for confidentiality, reporting, or publication. Its core practical function is to ensure that all parties understand the boundaries and obligations related to the use of resources in research, thereby protecting proprietary interests and maintaining compliance with ethical or legal standards.
In Studies. Persons who were genotype 1 with decompensated (severe) cirrhosis who were treated with daclatasvir and sofosbuvir with ribavirin for 12 weeks had a response rate of 83%. The response rate in those who were Child-▇▇▇▇ B was 94% and in those whose cirrhosis was Child-▇▇▇▇ C the response was 56%. Those who had Genotype 3 with decompensated cirrhosis had an 83% response. Persons with genotype 3 who had compensated (mild) cirrhosis were treated with daclatasvir and sofosbuvir for 12 weeks and had a 58% response. The European compassionate-use program treated persons with genotype 3 and cirrhosis for 24 weeks with daclatasvir and sofosbuvir and had an 86% response. Pending further data treatment extension and the addition of ribavirin is recommended. Persons with genotype 3 without cirrhosis who had previous treatment with sofosbuvir plus ribavirin that failed were treated with daclatasvir and sofosbuvir for 12 weeks and had a 71% response. Based on this limited data it is recommended to extend treatment duration to 24 weeks and add ribavirin. There is limited data for retreating persons with genotype 3 and cirrhosis whose previous treatment has failed. Genotype 3 cirrhotic patients given daclatasvir and sofosbuvir with ribavirin for 12 or 16 weeks had an 88% and 89% response rate. Therefore, it is recommended that persons with genotype 3 and compensated (mild) cirrhosis whose previous treatment with sofosbuvir plus ribavirin or peginterferon and ribavirin failed receive daclatasvir plus sofosbuvir and ribavirin for 24 weeks pending additional data.
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In Studies. Persons with genotype 1 without cirrhosis who previously failed treatment with a sofosbuvir plus ribavirin containing regimen with or without peginterferon alfa were treated with Harvoni® & ribavirin for 12 weeks and had a 100% response (cure) rate. Persons with genotype 1 who had cirrhosis and previously failed treatment were treated with Harvoni® and ribavirin for 12 weeks and had a 96% response (cure) rate. Persons who had decompensated cirrhosis and were treated with Harvoni® and ribavirin for 12 weeks had an 86% or better response (cure) rate. Persons with genotype 1 or 4 who had a recurrence of hepatitis C infection after transplant had a 95% or better response rate if they had mild to advanced fibrosis or mild cirrhosis. Those with genotype 1 who had moderate cirrhosis (Childs-▇▇▇▇ B) had an 87% response rate. Those with genotype 1 who had advanced cirrhosis (severe/Childs-▇▇▇▇ C) had an 88% response rate after a 12-week treatment course of Harvoni® and ribavirin.
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In Studies. Persons with genotype 1 who did not have cirrhosis were treated with daclatasvir and sofosbuvir for 12 weeks and had a 96% response (cure) rate. Those with cirrhosis had a 91% response. Persons with genotype 3 without cirrhosis had a 96% response rate after taking daclatasvir and sofosbuvir for 12 weeks. Those with cirrhosis had a 63% response rate after taking daclatasvir and sofosbuvir for 12 weeks. The European compassionate use program reported an 86% sustained virologic response rate (cure) in persons with genotype 3 with cirrhosis who were treated for 24 weeks. Those with severe cirrhosis (Childs ▇▇▇▇ B or C) had a 70.6% response.
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In Studies. Persons with genotype 1 or 4 who had decompensated cirrhosis and were treated with Harvoni® and ribavirin for 12 weeks had an 86% or better response (cure) rate (SOLAR-1). Persons with genotype 1 or 4 who had a recurrence of hepatitis C infection after transplant had a 95% or better response rate if they had mild to advanced fibrosis or mild cirrhosis. Those with genotype 1 who had moderate cirrhosis (Child-▇▇▇▇ B) had an 86% response rate. Those with genotype 1 who had advanced cirrhosis (severe/Child-▇▇▇▇ C) had a 60% response rate after a 12-week treatment course of Harvoni® and ribavirin (SOLAR-1). There is no available data for persons with genotype 5 or 6.  Do not share needles or other drug works, toothbrushes, razors, or nail clippers.  Cover cuts to prevent blood exposure.  Only get a tattoo if the equipment and ink used is sterile (such as at a commercial, regulated tattoo studio).  Practice safe sex.  Do not drink alcohol or use drugs because these hurt the liver. WHOM TO CALL If you have any questions, contact your primary care provider.
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In Studies. In the Optimist-2 study in which patients with cirrhosis were treated with simeprevir and sofosbuvir, sustained virologic response (cure) was achieved by 25 of 34 (74%) patients with HCV genotype 1a and the Q80K mutation and in 35 of 38 (92%) of patients with genotype 1a without the Q80K mutation. Ribavirin is recommended as part of all retreatment regimens for patients in whom prior treatment with NS5A inhibitors has failed.
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In Studies. Persons with genotype 1 without cirrhosis who were treated with simeprevir and sofosbuvir for 12 weeks had a 95% response rate. Those who were previously treated with pegylated interferon and ribavirin were treated with simeprevir and sofosbuvir for 12 weeks and had a 95% response rate.
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In Studies. Six persons with genotype 1a with baseline NS5A polymorphisms (mutations in the hepatitis C virus that can decrease response to treatment) treated with Zepatier™ and ribavirin for 16 weeks had a 100% response (cure) rate. Persons who had genotype 1a or 1b previously treated with Peg-interferon, ribavirin and a protease inhibitor (boceprevir, simeprevir, or telaprevir) and took Zepatier™ and ribavirin for 12 weeks had an overall 96% response (cure) rate. Five persons with genotype 4 whose previous treatment with peginterferon and ribavirin failed, took Zepatier™ and ribavirin for 16 weeks and had a 100% response (cure) rate.
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Related to In Studies

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.