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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
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| Paper Title: | A Review on Investigators Brochure |
| Authors Name: | Kethavaram.Rahamthulla , Dr.B.V.Ramana |
| Download E-Certificate: | Download |
| Author Reg. ID: |
IJNRD_187396
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| Published Paper Id: | IJNRD2302186 |
| Published In: | Volume 8 Issue 2, February-2023 |
| DOI: | |
| Abstract: | The Multidisciplinary Association for Psychedelic Studies (MAPS) is a U.S.-based non-profit research and educational organization that supports research into the therapeutic potential of hallucinogenic compounds and cannabis. MAPS is working to obtain approval for the prescriptionuse of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with posttraumatic stress disorder (PTSD). This document is the sixth edition of MAPS’ Investigator’s Brochure (IB) for MDMA. It describes the physical, chemical and pharmacological characteristics of MDMA, its effects in nonclinical andclinical studies, and the safety profile of MDMA-assisted psychotherapy. This IB focuses on research and information relevant to researchers and regulators engaged in clinical trials with MDM. |
| Keywords: | ADHD - Attention Deficit Hyperactivity Disorder AE(s)-Adverse Event(s) ALT/SGPT- Alanine aminotransferase AMI -Acute Myocardial Infarction AST/SGOT-Aspartate aminotransferase BDI-II -Beck Depression Inventory CAPS- Clinician Administered CNS-Central Nervous System CPK - Creatine Phosphokinase CRA - Clinical Research Associate CRF(s) -Case Report Form(s) C-SSRS-Columbia Suicide Severity Rating Scale DEA --Drug Enforcement Administration DBP - Diastolic Blood Pressure DMF - Drug Master File DSM-IV - Diagnostic and Statistical Manual of Mental Disorders – EMDR - Eye Movement Desensitization and Reprocessing EMEA-European Medicines Agency ESR -- Erythrocyte Sedimentation Rate EU - European Union FDA - Food and Drug Administration GAF Global Assessment of Functioning GCP Good Clinical Practice HCl - Hydrochloride HIPAA - Health Insurance Portability and Accountability ActHIV HPLC - High Performance Liquid Chromatography ICF - Informed Consent Form ICH - International Conference on Harmonization IND Investigational New Drug IRB - Institutional Review Board ISF - Investigator Site File IV - intravenous EMEA - European Medicines Agency LD50 Lethal dose in 50% of cases LSD - d-lysergic acid diethylamide MAOI Monoamine oxidase inhibitor MAPS - Multidisciplinary Association for Psychedelic Studies MCH Mean Corpuscular Hemoglobin MCHC - Mean Corpuscular Hemoglobin Concentration MCV Mean Corpuscular Volume MDMA - 3,4-methylenedioxymethamphetamine MP-1- Sponsor’s first Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD PRN - As needed PT - Prothrombin Time PTCA - Percutaneous Transluminal Coronary Angioplasty PTSD- Posttraumatic Stress Disorder PTT - Partial Thromboplastin Time RBC - Red Blood Cell Count RDW - Red Cell Distribution Width RRPQ - Reactions to Research Participation Questionnaire SAE(s)- Serious Adverse Event(s) SBP - Systolic Blood Pressure SCID -Structured Clinical Interview for Diagnoses SERT- Serotonin Transporter SL -Sublingual SNRI - Selective Serotonin and Norepinephrine Uptake Inhibitor SOP(s)- Standard Operating Procedure(s) SSRI - Selective Serotonin Reuptake Inhibitor SUD -Subjective Units of Distress |
| Cite Article: | "A Review on Investigators Brochure", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 2, page no.b833-b846, February-2023, Available :http://www.ijnrd.org/papers/IJNRD2302186.pdf |
| Downloads: | 000118750 |
| ISSN: |
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID:IJNRD2302186 Registration ID: 187396 Published In: Volume 8 Issue 2, February-2023 DOI (Digital Object Identifier): Page No: b833-b846 Country: nandi kotkur,nandyala(dist), Andhra Pradesh, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2302186 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2302186 |
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