{"component": "definition", "props": {"groups": [{"snippet_links": [{"key": "in-relation-to", "type": "clause", "offset": [0, 14]}, {"key": "ability-to", "type": "clause", "offset": [32, 42]}, {"key": "clinical-setting", "type": "definition", "offset": [86, 102]}], "size": 11, "samples": [{"hash": "c7NjefsPM2U", "uri": "https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/NEW%20DRUGS%20ANDctrS%20RULE,%202019.pdf", "label": "cdsco.gov.in", "score": 17.7835134503, "published": false}, {"hash": "5nagS1ROkEc", "uri": "https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/new_DC_rules/23NEW%20DRUGS%20AND%20CLINICAL%20TRIALS%20RULES,%202019.pdf", "label": "cdsco.gov.in", "score": 17.7791072746, "published": false}, {"hash": "et4AV3sz0oZ", "uri": "https://kledeemeduniversity.edu.in/wp-content/uploads/2024/05/New_Drugs_CT_Rules.pdf", "label": "kledeemeduniversity.edu.in", "score": 14.1418650128, "published": false}], "snippet": "in relation to a drug means its ability to achieve the desired effect in a controlled clinical setting;", "hash": "72903a8f1f1cd190739ff1e7324ee064", "id": 1}, {"snippet_links": [{"key": "the-device", "type": "clause", "offset": [133, 143]}, {"key": "as-intended", "type": "definition", "offset": [152, 163]}, {"key": "the-manufacturer", "type": "definition", "offset": [167, 183]}], "size": 5, "samples": [{"hash": "3CMWzrSo2gQ", "uri": "https://data.consilium.europa.eu/doc/document/ST-16893-2014-REV-1/en/pdf", "label": "data.consilium.europa.eu", "score": 7.7364818617, "published": false}], "snippet": "means the ability of a medical device to achieve the intended clinical benefit(s) to patients, in the intended target group(s), when the device is used as intended by the manufacturer, under ideal circumstances (as in a pre-market clinical investigation); 120", "hash": "bdcc931c8d8b22836c410ff2304eca06", "id": 2}, {"snippet_links": [{"key": "concerning-the", "type": "clause", "offset": [16, 30]}, {"key": "application-of", "type": "clause", "offset": [53, 67]}, {"key": "protection-product", "type": "definition", "offset": [76, 94]}, {"key": "development-of", "type": "clause", "offset": [274, 288]}], "size": 4, "samples": [{"hash": "cB4zSe89Pmp", "uri": "https://www.wko.at/oe/news/psm-daten-zulassung-anhang.pdf", "label": "www.wko.at", "score": 16.4782792137, "published": false}, {"hash": "ltoARxTTvYx", "uri": "https://docs.wto.org/dol2fe/Pages/FE_Search/ExportFile.aspx?id=278359&filename=2021/TBT/EEC/21_6921_01_e.pdf&Open=True", "label": "docs.wto.org", "score": 10.909650924, "published": false}], "snippet": "means a measure concerning the overall effect of the application of a plant protection product on the agricultural system in which it is used (i.e. which includes positive effects of treatment in performing the desired plant protection activity and negative effects such as development of resistance);", "hash": "f1402c459cd8f2b5bcca548e013d8ad2", "id": 3}, {"snippet_links": [{"key": "program-committee", "type": "definition", "offset": [42, 59]}, {"key": "commercially-viable", "type": "definition", "offset": [100, 119]}, {"key": "beginning-of-the", "type": "clause", "offset": [204, 220]}, {"key": "deemed-necessary", "type": "definition", "offset": [272, 288]}, {"key": "duration-of-the-program", "type": "clause", "offset": [330, 353]}], "size": 3, "samples": [{"hash": "9vy93lbuswL", "uri": "/contracts/9vy93lbuswL#efficacy", "label": "Collaborative Research & Development Agreement", "score": 31.340862423, "published": true}, {"hash": "fVIArQmn1fb", "uri": "/contracts/fVIArQmn1fb#efficacy", "label": "Collaborative Research & Development Agreement (Arcadia Biosciences, Inc.)", "score": 26.1279945243, "published": true}, {"hash": "a6FWZ9wXJiW", "uri": "/contracts/a6FWZ9wXJiW#efficacy", "label": "Collaborative Research & Development Agreement (Arcadia Biosciences, Inc.)", "score": 25.9719370294, "published": true}], "snippet": "shall have the meaning established by the Program Committee. Fundamentally, \u201cEfficacy\u201d shall mean a commercially viable level of value creation, which shall be established by the Program Committee at the beginning of the Program, and which can be reviewed, and amended if deemed necessary, by the Program Committee throughout the duration of the Program.", "hash": "9872c3c033c9a7a844458f1549b53e07", "id": 4}, {"snippet_links": [{"key": "the-court", "type": "clause", "offset": [55, 64]}, {"key": "terms-of", "type": "clause", "offset": [99, 107]}, {"key": "supreme-court", "type": "definition", "offset": [170, 183]}], "size": 2, "samples": [{"hash": "emhewAWAxGm", "uri": "https://www.cedl.ac.in/pdf/volume1issu1/3.pdf", "label": "www.cedl.ac.in", "score": 6.4442162902, "published": false}, {"hash": "3gt8ijvjemK", "uri": "http://www.cedl.ac.in/wp-content/uploads/2015/11/chapters-vol1-issue-1.pdf", "label": "www.cedl.ac.in", "score": 5.5817932923, "published": false}], "snippet": ". \u201eEfficacy\u201f now clearly means \u201etherapeutic efficacy\u201f. The Court clearly rules out any efficacy in terms of properties. The following section summarizes the reasoning of Supreme Court", "hash": "2e93e40e29861dbbbfb299ef4e070c00", "id": 5}, {"snippet_links": [{"key": "duration-of-use", "type": "clause", "offset": [66, 81]}, {"key": "route-of-administration", "type": "definition", "offset": [94, 117]}, {"key": "the-manufacturer", "type": "definition", "offset": [129, 145]}], "size": 2, "samples": [{"hash": "7aLlNFtm35s", "uri": "https://cahfsa.org/wp-content/uploads/2022/10/Caribbean-Model-Pesticides-Bill-August-2020.pdf", "label": "cahfsa.org", "score": 11.3969883641, "published": false}], "snippet": "means the degree of effectiveness at the dose rate, frequency and duration of use, and by the route of administration claimed by the manufacturer;", "hash": "eecfef4350870acc45f13a0218602594", "id": 6}, {"snippet_links": [{"key": "initiation-of-treatment", "type": "clause", "offset": [21, 44]}, {"key": "loss-of", "type": "clause", "offset": [69, 76]}, {"key": "visual-acuity", "type": "definition", "offset": [112, 125]}], "size": 1, "samples": [{"hash": "42Jr32MBqIc", "uri": "https://www.pearceip.law/wp-content/uploads/2022/11/IPR2021-00881-FD.pdf", "label": "www.pearceip.law", "score": 7.4271047228, "published": false}], "snippet": "means that, from the initiation of treatment, the patient exhibits a loss of 15 or fewer letters on the [ETDRS] visual acuity chart. In certain embodiments, \u201cefficacy\u201d means a gain of one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or more) letters on the ETDRS chart from the time of initiation of treatment.", "hash": "12425378b72420cf39c51a4c045db0ec", "id": 7}, {"snippet_links": [], "size": 1, "samples": [{"hash": "bynXxcGHQ8c", "uri": "https://tradebarriers.org/library/regulations/Uganda/National%20Drug%20Authority%20Guidelines%20for%20Conduct%20of%20Ectoparasiticide%20Trials%20.pdf", "label": "tradebarriers.org", "score": 17.0746031717, "published": false}], "snippet": "means the extent to which a drug works under ideal circumstances i.e. in trials and a laboratory study;", "hash": "ebbccdeedb63a48eae8439a427ded6ab", "id": 8}, {"snippet_links": [{"key": "evaluation-tool", "type": "definition", "offset": [29, 44]}, {"key": "professional-practice", "type": "definition", "offset": [80, 101]}], "size": 1, "samples": [{"hash": "fO02BD4rqB7", "uri": "https://www.michigan.gov/documents/opt/2017_AACS_339.23401_400.20607_616806_7.pdf", "label": "www.michigan.gov", "score": 9.1752224504, "published": false}], "snippet": "means the extent to which an evaluation tool provides information that improves professional practice.", "hash": "c7aaffe180b7082756f84d3d4e413d2e", "id": 9}, {"snippet_links": [{"key": "ability-to", "type": "clause", "offset": [10, 20]}, {"key": "the-context", "type": "clause", "offset": [90, 101]}, {"key": "the-product", "type": "clause", "offset": [164, 175]}, {"key": "under-consideration", "type": "definition", "offset": [176, 195]}, {"key": "the-function", "type": "clause", "offset": [286, 298]}, {"key": "purpose-of-the", "type": "clause", "offset": [315, 329]}, {"key": "in-the-case", "type": "clause", "offset": [384, 395]}, {"key": "and-benefits", "type": "clause", "offset": [604, 616]}, {"key": "with-regard-to", "type": "clause", "offset": [705, 719]}], "size": 1, "samples": [{"hash": "cF5mTvYgWLl", "uri": "https://www.icsi.edu/media/webmodules/student/GA_PP_MODULE_3_DEC2022.pdf", "label": "www.icsi.edu", "score": 11.5708418891, "published": false}], "snippet": "means the ability to produce a desired or intended result. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, for instance, in the case of a medicine that claims to cure a disease, the test of efficacy can only be \u201ctherapeutic efficacy\u201d. The question then arises: what would be the parameter of therapeutic efficacy and what are the advantages and benefits that may be taken into account for determining the enhancement of therapeutic efficacy? With regard to the genesis and the circumstances in which section 3(d) was amended there is no doubt that the \u201ctherapeutic efficacy\u201d of a medicine must be judged strictly and narrowly. This provides an inference that the test of enhanced efficacy in", "hash": "7116a1059c7568921aa9b65909897d76", "id": 10}], "next_curs": "ClUST2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjELEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIRZWZmaWNhY3kjMDAwMDAwMGEMogECZW4YACAA", "definition": {"size": 40, "title": "efficacy", "snippet": "in relation to a drug means its ability to achieve the desired effect in a controlled clinical setting;", "id": "efficacy", "examples": [], "related": [["endpoint", "Endpoint", "Endpoint"], ["stability", "Stability", "Stability"], ["diagnosis", "Diagnosis", "Diagnosis"], ["study", "Study", "Study"], ["clinical", "Clinical", "Clinical"]], "related_snippets": [], "updated": "2025-07-06T21:58:41+00:00"}, "json": true, "cursor": ""}}