Study Drugs means the Antigen Express Study Drug and the Merck Study Drug.
Study Drugs all drugs, used in the framework of the Study including IMP(s) (investigational medicinal product(s)) and AMP(s) (auxiliary medicinal product(s)), as further detailed in the Protocol.
Study Drugs. RP103: Cysteamine Bitartrate Delayed-release Capsules (75 mg and 25 mg of cysteamine free-base per capsule).
Examples of Study Drugs in a sentence
Early Study Drugs Discontinuation visit to occur within 72 hours of last dose of study drug.
Additionally: TSH will be analyzed at Screening, Day 1, Weeks 24, 48, 72 and 96 followed by every 24 weeks post Week 96, Unblinding Visit and Early Study Drugs Discontinuation visit.
Additionally, TSH will be analyzed at Screening, Day 1, Weeks 24, 48, followed by every 24 weeks post Week 48, and Early Study Drugs Discontinuation visit.
Only required for those subjects who permanently discontinue study drugs prior to Week 48 visit and do not continue in the study through at least one subsequent visit after the Early Study Drugs Discontinuation Visit.
Additionally: TSH will be analyzed at Screening, Day 1, Weeks 24, 48, 72, 96, 120, 144, and every 24 weeks post Week 144, End of Blinded Treatment Visit and Early Study Drugs Discontinuation visit.j Fasting (no food or drinks, except water, at least 8 hours prior to blood collection) glucose and lipid panel (total cholesterol, HDL, direct LDL, triglycerides).
More Definitions of Study Drugs
Study Drugs. (Including test, comparator, dosage form, dosing regimen and route) No. Participants: No. Centres:
Study Drugs means the investigational medicinal products and includes the medicinal products under investigation, xx for this study Suspected Unexpected Serious Adverse Reaction “SUSAR” means a Serious Adverse Reaction the nature or severity of which is not consistent with the reference safety information;
Study Drugs. The investigational study drug Psilocybin “COMP 360”, formulated as described in the Protocol and manufactured and supplied by the Sponsor or by third party engaged by Sponsor. Study Drug is not psilocybin purchashed and/or manufactured from different sources other than Sponsor and used in investigations preformed by the Investigator outside and different from the Study.
Study Drugs means, with respect to each Clinical Study, the active drug(s) and placebo that is the subject of such Clinical Study, as more particularly described in the Task Order applicable thereto.
Study Drugs means the EQRx Study Drug and the TPT Study Drug. A “Study Drug” means either the EQRX Study Drug or the TPT Study Drug, as applicable.
Study Drugs means those substances referred to in the Protocol.
Study Drugs means all drugs, used in the framework of the Study, including IMP if any. “Study Steering Committee”: a group of representatives from the EORTC, and representatives from participating groups, with the overall responsibility to supervise the Study and ensure its scientific integrity “Study Subject”: patients selected in accordance with, and who meet, the eligibility criteria specified in the Protocol. “Results”: all results and/or data obtained within the framework of the Study, and specifically as written out in the final Study report (“Final Study Report”) 1. DEFINIZIONI I termini di seguito indicati assumono il seguente significato: “Contratto”: indica il presente contratto per studio clinico, i suoi documenti allegati e tutti gli emendamenti di seguito firmati dalle Parti. “Proprietà intellettuale preesistente”: indica la proprietà intellettuale che esisteva già prima di questo Contratto o è stata sviluppata in maniera indipendente dal presente Contratto da una qualsiasi delle Parti. “CRF” o “Schede raccolta dati”: indica le cartelle cliniche elettroniche o cartacee concepite per archiviare tutte le informazioni previste dal Protocollo da segnalare su ogni Soggetto in studio. “Database”: indica il mezzo elettronico concepito da EORTC/Gruppo per esigenze legate allo Studio, contenente tutte le informazioni ad esso relative. “HBM” o “Materiale biologico umano”: indica tutti i tessuti e/o fluidi e qualsiasi materiale da essi derivato, modificato e/o non modificato, sotto forma di, a titolo meramente esemplificativo, proteine, DNA, RNA, campioni inclusi in paraffina, campioni congelati, raccolti e/o usati nell’ambito dello Studio, conformemente al Protocollo e al documento di consenso informato firmato dal Soggetto in studio. “IMP” o “Medicinale sperimentale”: indica il farmaco specificamente etichettato e fornito per lo Studio dal Promotore. “Comitato etico”: indica il/i comitato/i etico/i istituito/i ai sensi dei requisiti normativi e giuridici locali, allo scopo di revisionare e/o approvare le sperimentazioni cliniche. “Gruppo leader”: EORTC, che coordina, unitamente a tutte le parti coinvolte (gruppi partecipanti, promotori di Paesi terzi, l’azienda, ecc.), la realizzazione dello Studio “Promotore legale”: EORTC è la persona giuridica che si assume la piena responsabilità per l’avvio e la conduzione di questo Studio conformemente al Protocollo e ai requisiti normativi e giuridici. “Rappresentante legale”: indica il soggetto operante presso il Centro pa...