DOCSLIB.ORG

BIOANALYTICAL Methodsat

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
BIOANALYTICAL Methodsat HANDBOOK OF BIOANALYTICALEdition: METHODS January 2015at LAMBDA THERAPEUTIC RESEARCH Edition: FEBRUARY 2020 Bio-analytical Lambda is one of the most experienced Bioanalytical service providers in India. We provide these services from two different strategic locations - India and Canada. Our highly qualified and experienced scientists work 24x7 and have an accumulated global catalogue of more than 1200 validated methods. Our vast expertise and in-depth understanding of the stringent regulatory demands ensures each project is accomplished in rapid turn-around times. qualified (Ph. D, M. Pharm, M.Sc, B.Pharm) and experience team comprising of 150+ research professionals GLP certified Bioanalytical labs in India and Canada Capabilities of analyzing 90,000+ samples per month on 50+ LC-MS/MS 7-8 new methods in development/month with expertise in handling different matrices such as plasma, serum, urine, whole blood, milk, food, bone, stool and animal tissues Infrastructure Separate well equipped extraction labs and chromatography labs. Separate lab for photosensitive drug. Separate room for storage of standards / balance room. Low temperature storage (-22 ± 5 °C, -65 ± 10 °C) Biolyte (Chromatographic Data review and data printing software) Different types of 50+ LC-MS/MS systems (including API 6500 and Waters Xevo TQ-S) Regulatory Track Record Table of Contents Title Page Large Molecules / Therapeutic Proteins / Biosimilars ............... 1 Small Molecules ............... 2 New Chemical Entities ............... 71 In‐Vitro Studies ............... 72 Immunogenicity Assesment ............... 73 PD Markers ............... 74 Evaluation Of Effectiveness Of Healthcare Hygiene Products ............... 76 Lambda Therapeutic Research LARGE MOLECULES / THERAPEUTIC PROTEINS / BIOSIMILARS Instrument/Method of Sr. No. Drug Name Matrix Range Anticoagulant Dose Analysis Location : India Human 1 Bevacizumab Sandwich ELISA 150 to 6000 ng / mL NA NA Serum Human 2 *Bevacizumab LC-MS/MS (6500 QTRAP) 5 to 500 µg / mL NA NA Serum Human 3 Darbepoetin Sandwich ELISA 0.075 to 2.6 ng / mL NA 0.45µg/kg Serum Human 4 Denosumab Sandwich ELISA 160 to 10000 ng / mL NA 60 mg Serum Human 5 Erythropoietin Sandwich ELISA 5.005 to 200 mIU / mL NA 50IU/kg Serum Human 6 Etanercept Sandwich ELISA 39.063 to 5000 ng / mL NA 50mg Serum Human 7Glucagon LC-MS/MS (Waters XEVO TQ-S) 0.2 to 10 ng / mL K EDTA 1 mg/vial Plasma 2 Human 8 PEG G-CSF Sandwich ELISA 0.150 to 10 ng / mL NA 6mg /0.6 mL SC Serum Electrochemiluminescence Human 0.156 to 20 mIU/mL 9 rHu-FSH NA 300 IU Immunoassay Serum Human 10 Rituximab Competitive ELISA 50 to 1502 ng / mL K EDTA 100mg/10mL Plasma 2 Human 11 *Romiplostim Sandwich ELISA 0.040 to 5.000 ng/mL NA 250 µg/0.5 mL Serum 12 *Teriparatide LC-MS/MS (6500 QTRAP) Human 5 to 500 pg / mL NA NA Serum Human 13 Teriparatide Sandwich ELISA 10 to 400 pg / mL NA NA Serum Human 14 Trastuzumab LC-MS/MS (6500 QTRAP) 5 to 500 µg / mL NA 8 mg / Kg Serum Human 15 *Trastuzumab Competitive ELISA 9.7 to 625 ng / mL NA NA Serum *: Developed method available Page 1 of 76 Lambda Therapeutic Research SMALL MOLECULES New / Sr. No. Drug Name Instrument Matrix Range Anticoagulant Dose Modified Method A Location : Canada LC-MS/MS Human 1 Acetaminophen 0.1 to 13 µg / mL K EDTA - (API 300 or 3000) Plasma 2 LC-MS/MS Human 2 Acetaminophen 0.1 to 13 µg / mL K EDTA 320 mg (Waters QPXE) Plasma 2 Human 3 Acyclovir HPLC-UV 5 to 1280 ng / mL Heparin - Plasma HPLC Human Sodium 4 Acyclovir 10 to 2560 ng / mL - - Flurosence Plasma heparin HPLC Human Sodium 5 Acyclovir 20 to 2560 ng / mL - Flurosence Plasma heparin LC-MS/MS Human 6 Acyclovir 5 to 1600 ng / mL K EDTA 200 mg (Thermo) Plasma 2 LC-MS/MS Human 7 Alverine 0.05 to 10 ng / mL K EDTA 120 mg (Thermo) Plasma 2 LC-MS/MS Human 8 Allopurinol 10 to 5000 ng/mL K EDTA 200 mg (Thermo) Plasma 2 LC-MS/MS Human 9Amantadine 2 to 1500 ng / mL K EDTA 300mg (Waters QPXE) Plasma 2 LC-MS/MS Human Not 10 Amantadine 20 to 3000 ng / mL 160 mg (Thermo) Urine applicable LC-MS/MS Human Amitriptyline 0.4 to 51 ng / mL K EDTA - (API 3000) Plasma 2 11 LC-MS/MS Human Nortriptyline 0.4 to 51 ng / mL K EDTA - (API 3000) Plasma 2 LC-MS/MS Human 12 Amlodipine 0.1 to 13 ng / mL K EDTA 10 mg (API 3000) Plasma 3 LC-MS/MS Human D-Amphetamine 0.5 to 100 ng / mL K EDTA (API 6500) Plasma 2 13 30 mg LC-MS/MS Human L-Amphetamine 0.15 to 30 ng/mL K EDTA (API 6500) Plasma 2 C A N D LC-MS/MS Human 14 Amphotericin B 5 to 5000 ng / mL K EDTA 200 to 400 mg (Waters QPXE) Plasma 2 LC-MS/MS Human 15 Alectinib 1 to 600 ng/mL K EDTA 50mg (Thermo) Plasma 2 LC-MS/MS Human 16 Alectinib 1 to 600 ng/mL K EDTA 150 mg (Thermo) Plasma 2 LC-MS/MS Human Not 17 Alendronate 1 to 256 ng / mL - (API 3000) Urine applicable LC-MS/MS Human 18 Anastrozole 0.1 to 26 ng / mL K EDTA 1 mg (API 3000) Plasma 2 LC-MS/MS Human 19 Atomoxetine 0.500 to 500 ng/mL K EDTA 10 mg (Thermo) Plasma 2 LC-MS/MS Human 20 Atomoxetine 2.5 to 2500 ng/mL K EDTA 60 mg (Thermo) Plasma 2 LC-MS/MS Human Atomoxetine 2 to 512 ng / mL K EDTA 40 mg (Thermo) Plasma 2 LC-MS/MS Human 21 4-Hydroxyatomoxetine 2 to 512 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human N-Desmethylatomoxetine 2 to 512 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human Sodium 22 Atorvastatin 0.3 to 300 ng/mL 80 mg (Thermo) Plasma heparin LC-MS/MS Human Atorvastatin 0.4 to 102 ng / mL K EDTA 80 mg (Thermo) Plasma 2 LC-MS/MS Human 23 o-hydroxyatorvastatin 0.4 to 102.5 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human p-hydroxyatorvastatin 0.04 to 10 ng / mL K EDTA - (Thermo) Plasma 2 Page 2 of 76 Lambda Therapeutic Research SMALL MOLECULES New / Sr. No. Drug Name Instrument Matrix Range Anticoagulant Dose Modified Method LC-MS/MS Dog Atorvastatin 0.25 to 2500 ng / mL K EDTA 5 mg to 80 mg (Thermo) Plasma 2 LC-MS/MS Dog o-hydroxyatorvastatin 0.25 to 500 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Dog p-hydroxyatorvastatin 0.25 to 500 ng / mL K EDTA - (Thermo) Plasma 2 24 LC-MS/MS Dog Atorvastatin Lactone 0.5 to 2500 ng / mL K EDTA - (Thermo) Plasma 2 o-Hydroxy Atorvastatin LC-MS/MS Dog 0.5 to 250 ng / mL K EDTA - Lactone (Thermo) Plasma 2 p-Hydroxy Atorvastatin LC-MS/MS Dog 0.5 to 250 ng / mL K EDTA - Lactone (Thermo) Plasma 2 LC-MS/MS Dog Atorvastatin 10 to 2500 ng / mL K EDTA 5 mg to 80 mg (Thermo) Plasma 2 LC-MS/MS Dog o-hydroxyatorvastatin 1 to 250 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Dog p-hydroxyatorvastatin 1 to 250 ng / mL K EDTA - (Thermo) Plasma 2 25 LC-MS/MS Dog Atorvastatin Lactone 10 to 2500 ng / mL K EDTA - (Thermo) Plasma 2 o-Hydroxy Atorvastatin LC-MS/MS Dog 1 to 250 ng / mL K EDTA - Lactone (Thermo) Plasma 2 p-Hydroxy Atorvastatin LC-MS/MS Dog 1 to 250 ng / mL K EDTA - Lactone (Thermo) Plasma 2 C A N D LC-MS/MS Human Atorvastatin 10 to 15000 pg / mL K EDTA 10 mg (Thermo) Plasma 2 LC-MS/MS Human 26 o-Hydroxy Atorvastatin 10 to 10000 pg / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human p-Hydroxy Atorvastatin 10 to 5000 pg / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human Atorvastatin 0.1 to 40 ng / mL K EDTA 20 mg (Thermo) Plasma 2 LC-MS/MS Human o-Hydroxy Atorvastatin 0.1 to 40 ng / mL K EDTA - (Thermo) Plasma 2 27 LC-MS/MS Human p-Hydroxy Atorvastatin 0.05 to 20 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human Glimepiride 0.5 to 200 ng / mL K EDTA - (Thermo) Plasma 2 LC-MS/MS Human 28 Atazanavir 20 to 8000 ng/mL K EDTA 300 mg (Thermo) Plasma 2 LC-MS/MS Human 29 Axitinib 0.1 to 100 ng/mL K EDTA 5 mg (Thermo) Plasma 2 LC-MS Human Sodium 30 Azithromycin 5 to 1280 ng / mL 600 mg (API 150) Plasma heparin Location : India LC-MS/MS Human 31 Abacavir 10 to 6000 ng / mL K EDTA 300 mg (Waters QPXE) Plasma 2 LC-MS/MS Human Abacavir 25 to 12000 ng / mL K EDTA 600 mg (Waters QPXE) Plasma 2 32 LC-MS/MS Human Lamivudine 25 to 6000 ng / mL K2EDTA 300 mg I N D I A D I N (Waters QPXE) Plasma LC-MS/MS Human Abacavir 25 to 10000 ng / mL K EDTA 300mg (Waters QPXE) Plasma 2 33 LC-MS/MS Human Lamivudine 20 to 5000 ng / mL K EDTA 150mg (Waters QPXE) Plasma 2 Page 3 of 76 Lambda Therapeutic Research SMALL MOLECULES New / Sr. No. Drug Name Instrument Matrix Range Anticoagulant Dose Modified Method LC-MS/MS Human Abacavir 25 to 6000 ng/mL K EDTA 300mg (Shimadzu 8045) Plasma 2 34 LC-MS/MS Human Lamivudine 20 to 5000 ng/mL K EDTA 150mg (Shimadzu 8045) Plasma 2 LC-MS/MS Human 35 Abiraterone 0.250 to 100 ng/mL K EDTA 250 mg (Thermo) Plasma 2 LC-MS/MS Human 2 X 333 mg i.e.
Load more

Recommended publications
  • T.C. Süleyman Demirel Üniversitesi Fen Bilimleri Enstitüsü Bazi Antidepresan Ilaç Numunelerinin Pcr Ve Pls
    T.C. SÜLEYMAN DEMİREL ÜNİVERSİTESİ FEN BİLİMLERİ ENSTİTÜSÜ BAZI ANTİDEPRESAN İLAÇ NUMUNELERİNİN PCR VE PLS İLE SPEKTROFOTOMETRİK TAYİNLERİ Nuray AYTEKİN Danışman Prof. Dr. Ahmet Hakan AKTAŞ YÜKSEK LİSANS TEZİ KİMYA ANABİLİM DALI ISPARTA - 2014 2 © 2014 [Nuray AYTEKİN] TAAHHÜTNAME Bu tezin akademik ve etik kurallara uygun olarak yazıldığını ve kullanılan tüm literatür bilgilerinin referans gösterilerek tezde yer aldığını beyan ederim. Nuray AYTEKİN ii İÇİNDEKİLER Sayfa İÇİNDEKİLER ......................................................................................................................... i ÖZET ......................................................................................................................................... iii ABSTRACT .............................................................................................................................. iv TEŞEKKÜR .............................................................................................................................. v ŞEKİLLER DİZİNİ ................................................................................................................. vi ÇİZELGELER DİZİNİ ............................................................................................................ vii SİMGELER VE KISALTMALAR DİZİNİ .......................................................................... viii 1. GİRİŞ..................................................................................................................................... 1 1.1. Sertralinenin
    [Show full text]
  • WO 2012/068516 A2 24 May 20 12 (24.05.2012) W P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2012/068516 A2 24 May 20 12 (24.05.2012) W P O P C T (51) International Patent Classification: (72) Inventors; and A61K 31/352 (2006.01) A61P 25/24 (2006.01) (75) Inventors/Applicants (for US only): LETENDRE, Peter A61K 9/48 (2006.01) A61P 25/22 (2006.01) [US/US]; 2389 Indian Peaks Trail, Lafayette, Colorado A61K 9/20 (2006.01) A61P 25/00 (2006.01) 80026 (US). CARLEY, David [US/US]; 2457 Pioneer Rd., Evanston, Illinois 60201 (US). (21) International Application Number: PCT/US201 1/061490 (74) Agents: FEDDE, Kenton et al; 18325 AUenton Woods Ct, Wildwood, Missouri 63069 (US). (22) International Filing Date: 18 November 201 1 (18.1 1.201 1) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (25) Language: English Filing AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (26) Publication Language: English CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, (30) Priority Data: HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, 61/415,33 1 18 November 2010 (18. 11.2010) US KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, (71) Applicant (for all designated States except US): PIER MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, PHARMACEUTICALS [US/US]; 901 Front St., Suite OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, 201, Louisville, Colorado 80027 (US).
    [Show full text]
  • Antidepressants, Other Review 04/14/2009
    Antidepressants, Other Review 04/14/2009 Copyright © 2004 - 2009 by Provider Synergies, L.L.C. All rights reserved. Printed in the United States of America. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage and retrieval system without the express written consent of Provider Synergies, L.L.C. All requests for permission should be mailed to: Attention: Copyright Administrator Intellectual Property Department Provider Synergies, L.L.C. 5181 Natorp Blvd., Suite 205 Mason, Ohio 45040 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be
    [Show full text]
  • Toxic, and Comatose-Fatal Blood-Plasma Concentrations (Mg/L) in Man
    Therapeutic (“normal”), toxic, and comatose-fatal blood-plasma concentrations (mg/L) in man Substance Blood-plasma concentration (mg/L) t½ (h) Ref. therapeutic (“normal”) toxic (from) comatose-fatal (from) Abacavir (ABC) 0.9-3.9308 appr. 1.5 [1,2] Acamprosate appr. 0.25-0.7231 1311 13-20232 [3], [4], [5] Acebutolol1 0.2-2 (0.5-1.26)1 15-20 3-11 [6], [7], [8] Acecainide see (N-Acetyl-) Procainamide Acecarbromal(um) 10-20 (sum) 25-30 Acemetacin see Indomet(h)acin Acenocoumarol 0.03-0.1197 0.1-0.15 3-11 [9], [3], [10], [11] Acetaldehyde 0-30 100-125 [10], [11] Acetaminophen see Paracetamol Acetazolamide (4-) 10-20267 25-30 2-6 (-13) [3], [12], [13], [14], [11] Acetohexamide 20-70 500 1.3 [15] Acetone (2-) 5-20 100-400; 20008 550 (6-)8-31 [11], [16], [17] Acetonitrile 0.77 32 [11] Acetyldigoxin 0.0005-0.00083 0.0025-0.003 0.005 40-70 [18], [19], [20], [21], [22], [23], [24], [25], [26], [27] 1 Substance Blood-plasma concentration (mg/L) t½ (h) Ref. therapeutic (“normal”) toxic (from) comatose-fatal (from) Acetylsalicylic acid (ASS, ASA) 20-2002 300-3502 (400-) 5002 3-202; 37 [28], [29], [30], [31], [32], [33], [34] Acitretin appr. 0.01-0.05112 2-46 [35], [36] Acrivastine -0.07 1-2 [8] Acyclovir 0.4-1.5203 2-583 [37], [3], [38], [39], [10] Adalimumab (TNF-antibody) appr. 5-9 146 [40] Adipiodone(-meglumine) 850-1200 0.5 [41] Äthanol see Ethanol -139 Agomelatine 0.007-0.3310 0.6311 1-2 [4] Ajmaline (0.1-) 0.53-2.21 (?) 5.58 1.3-1.6, 5-6 [3], [42] Albendazole 0.5-1.592 8-992 [43], [44], [45], [46] Albuterol see Salbutamol Alcuronium 0.3-3353 3.3±1.3 [47] Aldrin -0.0015 0.0035 50-1676 (as dieldrin) [11], [48] Alendronate (Alendronic acid) < 0.005322 -6 [49], [50], [51] Alfentanil 0.03-0.64 0.6-2.396 [52], [53], [54], [55] Alfuzosine 0.003-0.06 3-9 [8] 2 Substance Blood-plasma concentration (mg/L) t½ (h) Ref.
    [Show full text]
  • Antidepressants, Other Therapeutic Class Review (TCR)
    Antidepressants, Other Therapeutic Class Review (TCR) January 9, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. January
    [Show full text]
  • University of Groningen SSRI Augmentation Strategies Cremers
    University of Groningen SSRI augmentation strategies Cremers, Thomas Ivo Franciscus Hubert IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2002 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Cremers, T. I. F. H. (2002). SSRI augmentation strategies: pharmacodynamic and pharmacokinetic considerations. s.n. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license. More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne- amendment. Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 01-10-2021 Clinical efficacy of antidepressants in depression Chapter 2 Clinical efficacy of antidepressants in depression 33 Chapter 2 Introduction History Once the therapeutic effects of iproniazid and imipramine in major depression were recognized, pharmaceutical companies intensified research programs to develop superior antidepressants.
    [Show full text]
  • Drug Class Review
    Drug Class Review Miscellaneous and Serotonergic Agents 28:16.04.92 Antidepressants, Miscellaneous Bupropion (Wellbutrin®; Wellbutrin® SR; Wellbutrin® XL; Zyban®) Mirtazapine (Remeron®; Remeron® SolTab™) 28:16.04.24 Serotonin Modulators Nefazodone (Serzone®) Trazodone (Desyrel®) Vilazodone (Viibryd®) Vortioxetine (Trintellix®) 28:92 Central Nervous System Agents, Miscellaneous Atomoxetine (Strattera®) 28:28 Antimanic Agents Lithium (Eskalith CR®; Eskalith®; Lithobid® Slow-release) Final Report August 2016 Review prepared by: Melissa Archer, PharmD, Clinical Pharmacist Carin Steinvoort, PharmD, Clinical Pharmacist Vicki Frydrych, PharmD, Clinical Pharmacist Joanne LaFleur PharmD, MSPH, Associate Professor Gary Oderda, PharmD, MPH, Professor University of Utah College of Pharmacy Copyright © 2016 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved. 1 Contents Executive Summary ...................................................................................................................... 3 Introduction ................................................................................................................................... 6 Table 1. Comparison of the Miscellaneous and Serotonergic Agents ................................... 7 Table 2. Miscellaneous Serotonergic Agents FDA-Labeled Indications ............................. 10 Disease Overview ........................................................................................................................ 11 Table 3. Current Clinical Practice
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 6,469,008 B2 Currie Et Al
    USOO6469008B2 (12) United States Patent (10) Patent No.: US 6,469,008 B2 Currie et al. (45) Date of Patent: Oct. 22, 2002 (54) (R)-HYDROXYNEFAZODONE FOREIGN PATENT DOCUMENTS ANTIPSYCHOTIC THERAPY EP O769297 A1 4/1997 (75) Inventors: Mark G. Currie, Sterling, MA (US); OTHER PUBLICATIONS Thomas P. Jerussi, Framingham, MA (US); Paul D. Rubin, Sudbury, MA Green et al. “Clinical Pharmacokinetics of Nefazodone” (US) Clin. Pharmacokinet. 33, 260–275 (1997). Barbahaiya et al. “Single and Multiple Dose Pharmacoki (73) Assignee: Sepracor Inc., Marlborough, MA (US) netics of Nefazodone in Subjects Classified . .” Br. J. Clin. Pharm. 42,573–581 (1996). (*) Notice: Subject to any disclaimer, the term of this Cyr et al. “Nefazodone: Its Place Among Antidepressants' patent is extended or adjusted under 35 Ann. Pharmacother 30, 1006-12 (1996). U.S.C. 154(b) by 0 days. Malik “Nefazodone: structure, mode of action and pharma cokinetics”. J. Psychopharm. 10, 1-4 (1996). (21) Appl. No.: 09/992, 197 S.A. Montgomery “Efficacy of nefazodone in the treatment of depression” J. Psychopharm. 10, 5-10 (1996). (22) Filed: Nov. 14, 2001 Nacca et al. “Brain-to-blood partition and in vivo inhibition O O of 5-hydroxytryptamine reuptake . .” Br. J. Pharmac. 125, (65) Prior Publication Data 1617–1623 (1998). US 2002/0058675 A1 May 16, 2002 von Moltke et al. “Nefazodone, meta-chlorophenylpipera zine, and their metabolites . Psychopharma. 145, Related U.S. Application Data 113–122 (1999). Eison et a. “Nefazodone: Preclinical Pharmacology of a (63) Continuation-in-part of application No. 09/545,602, filed on New Antidepressant’ Psychopharma.
    [Show full text]
  • Metabolic Activation 73 2-Allylisopropylacetamide (AIA) 117F
    j377 Index a – terminal 117ff. abacavir 369f. allele association ABT, see 1-aminobenzotriazole – HLA 370 acetaminophen 71, 273ff. allopurinol 373 – metabolic activation 73 2-allylisopropylacetamide (AIA) 117f. – metabolism 72 alpidem 304f., 336, 349 acetaminophen-like metabolite 276 amanitin 204 N-acetyl-p-benzoquinone imine (NAPQI) Ames assay 29 5, 73 AMG 458 139ff. N-acetylcysteine 275 a-amidoacetonitrile 324 N-acetyltransferase (NAT) 16, 283 amine 49 N-acetyltransferase-2 (NAT-2) 79, 283 – aromatic, see aromatic amine acute liver failure (ALF) 363 – carcinogenicity of aromatic and acylating agent 320 heteroaromatic amine 13 afatinib 319 – drug–drug interaction 51 affinity label 313 amineptine 196, 342ff. aflatoxin 214 2-amino-3,8-dimethylimidazo[4,5-f] fl a atoxin B1 (AFB1)2 quinoxaline (MeIQx) 216 – bioactivation 215 – bioactivation 218 AKT inhibitor, see protein kinase B inhibitor 2-amino-1-methyl-6-phenylimidazo[4,5-b] alanine transaminase (ALT) 363 pyridine (PhIP) 216 alclofenac – bioactivation 218 – metabolic activation 119 aminoazo dye 15 aldehyde oxidase 60 1-aminobenzotriazole (ABT) 58f. alendronic acid 290 aminoglutethimide 188 alkaloid 5-aminooxindole 253 – pyrrolizidine 210 – derivative 254 alkene ortho-aminophenol 101 – terminal 117f. para-aminophenol 101 3-alkyl pyrrole 112 2-aminothiazole 109 – activation 112 amitriptyline 282ff., 343f. alkylating species 173 – metabolism 287 2-alkylimidazole 57 amlodipine 274 3-alkylindole analogue 113 amodiaquine 252 3-alkylindole derivative 112 – metabolic activation 101 alkylpiperazine 258 amoxicillin 132, 273ff., 288 alkyne 56f. angiotensin converting enzyme – bioactivation 119f. inhibitor 294ff. – internal 120 angiotensin II receptor antagonist 298 Reactive Drug Metabolites, First Edition. Amit S. Kalgutkar, Deepak Dalvie, R. Scott Obach, and Dennis A.
    [Show full text]
  • WO 2009/049018 Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 16 April 2009 (16.04.2009) WO 2009/049018 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/33 (2006.01) C07D 213/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, (21) International Application Number: CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, PCT/US2008/079298 EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, (22) International Filing Date: 9 October 2008 (09.10.2008) IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY,MA, MD, ME, MG, MK, MN, MW, (25) Filing Language: English MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, (26) Publication Language: English RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY,TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (30) Priority Data: ZW 60/978,955 10 October 2007 (10.10.2007) US (71) Applicant (for all designated States except US): SYN- (84) Designated States (unless otherwise indicated, for every DAX PHARMACEUTICALS, INC. [US/US]; 11260 El kind of regional protection available): ARIPO (BW, GH, Camino Real, Suite 220, San Diego, CA 92130 (US). GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), (72) Inventors; and European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, (75) Inventors/Applicants (for US only): KEANNA, John, FR, GB, GR, HR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, F.W.
    [Show full text]
  • Depression Following Spinal Cord Injury: a Clinical Practice Guideline for Primary Care Physicians CLINICAL PRACTICE GUIDELINE: DEPRESSION
    SPINAL CORD MEDICINE Depression Following Spinal Cord Injury: A Clinical Practice Guideline for Primary Care Physicians CLINICAL PRACTICE GUIDELINE: DEPRESSION Administrative and financial support provided by Paralyzed Veterans of America CLINICAL PRACTICE GUIDELINES Spinal Cord Medicine Depression Following Spinal Cord Injury: A Clinical Practice Guideline for Primary Care Physicians Consortium for Spinal Cord Medicine Administrative and financial support provided by Paralyzed Veterans of America © Copyright 1998, Paralyzed Veterans of America August 1998 This guide has been prepared based on scientific and professional information known about depression following spinal cord injury/dysfunction, its causes, and its treatments, in 1998. Users of this guide should periodically review this material to ensure that the advice herein is consistent with current reasonable clinical practice. CLINICAL PRACTICE GUIDELINES iii Contents v Foreword vii Preface ix Acknowledgments x Panel Members xi Contributors 1 Summary of Recommendations 3 The Spinal Cord Medicine Consortium GUIDELINES DEVELOPMENT PROCESS DEPRESSION GUIDELINES METHODOLOGY STRENGTH OF EVIDENCE 6 Treatment Recommendations ASSESSMENT DIAGNOSIS TREATMENT PSYCHOPHARMACOLOGICAL AGENTS PSYCHOPHARMACOLOGICAL GUIDELINES ANTIDEPRESSANT PHARMACOTHERAPY ENVIRONMENTAL AND SOCIAL FACTORS AND SOCIAL SUPPORT SYSTEMS CONSUMER AND FAMILY EDUCATION EVALUATION AND MODIFICATION OF TREATMENT PLAN 28 Directions for Future Research 30 Reference Section A 32 Reference Section B 34 Index CLINICAL PRACTICE
    [Show full text]
  • Buspar® (Buspirone Hcl, USP)
    Rx only ® BuSpar (buspirone HCl, USP) (Patient Instruction Sheet Included) DESCRIPTION BuSpar® (buspirone hydrochloride tablets, USP) is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1­ piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 • HCl is represented by the following structural formula: BuSpar is supplied as tablets for oral administration containing 5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in the DIVIDOSE® tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).
    [Show full text]