A Review on Investigators Brochure

Registration ID: IJNRD_187396

Published ID: IJNRD2302186

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Kethavaram.Rahamthulla , Dr.B.V.Ramana

 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

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.

Published Paper   E-Certificate

Kethavaram.Rahamthulla & Dr.B.V.Ramana (February-2023). A Review on Investigators Brochure. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(2), b833-b846. https://ijnrd.org/papers/IJNRD2302186.pdf

Volume 8 Issue 2, February-2023

Pages : b833-b846

Paper Reg. ID: IJNRD_187396

Published Paper Id: IJNRD2302186

Downloads: 000122254

Research Area: Pharmacy

Author Type: Indian Author

Country: nandi kotkur,nandyala(dist), Andhra Pradesh, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2302186.pdf

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