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Clinical trials and drug discovery & development 01-03-2011

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CLINICAL TRIALS: DRUG DISCOVERY – NEW DRUG DEVELOPMENT PROCESS BY Dr. M. Rafiq Khanani Associate Professor, Pathology, Dow International Medical College Director, Dow Diagnostic Reference & Research Lab Dow University of Health Sciences (DUHS) President, Infection Control Society Pakistan Pathologist Citilab Email: [email_address] , [email_address] www.duhs.edu.pk : www.infectioncontrolsociety.org
Global Clinical Trial Market ,[object Object]
Indian Clinical Research Business ,[object Object]
Why do the research studies? ,[object Object],[object Object],[object Object]
DRUG ,[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Continued How Drugs are Discovered
[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Continued How Drugs are Discovered
[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab How Drugs are Discovered
How Drugs are Developed ,[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Differences and Similarities of Drugs and Medicinal Plants ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Differences and Similarities of Drugs and Medicinal Plants ,[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Need for consumer education about Herbal supplements & Drugs ,[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
More is Not Always Better ,[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Acetyldigoxin Cardiotonic Digitalis lanata Adoniside Cardiotonic Adonis vernalis Aescin Anti-inflammatory Aesculus hippocastanum Aesculetin Anti-dysentery Frazinus rhychophylla Agrimophol Anthelmintic Agrimonia supatoria Ajmalicine Circulatory Disorders Rauvolfia sepentina Allantoin Vulnerary Several plants Allyl isothiocyanate Rubefacient Brassica nigra Anabesine Skeletal muscle relaxant Anabasis sphylla Andrographolide Baccillary dysentery Andrographis paniculata Anisodamine Anticholinergic Anisodus tanguticus
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Anisodine Anticholinergic Anisodus tanguticus Arecoline Anthelmintic Areca catechu Asiaticoside Vulnerary Centella asiatica Atropine Anticholinergic Atropa belladonna Benzyl benzoate Scabicide Several plants Berberine Bacillary dysentery Berberis vulgaris Bergenin Antitussive Ardisia japonica Betulinic acid Anticancerous Betula alba Borneol Antipyretic, analgesic, antiinflammatory Several plants Bromelain Anti-inflammatory, proteolytic Ananas comosus Caffeine CNS stimulant Camellia sinensis
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Cynarin Choleretic Cynara scolymus Danthron Laxative Cassia species Demecolcine Antitumor agent Colchicum autumnale Deserpidine Antihypertensive, tranquillizer Rauvolfia canescens Deslanoside Cardiotonic Digitalis lanata L-Dopa Anti-parkinsonism Mucuna sp Digitalin Cardiotonic Digitalis purpurea Digitoxin Cardiotonic Digitalis purpurea Digoxin Cardiotonic Digitalis purpurea Emetine Amoebicide, emetic Cephaelis ipecacuanha Ephedrine
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Etoposide Antitumor agent Podophyllum peltatum Galanthamine Cholinesterase inhibitor Lycoris squamigera Gitalin Cardiotonic Digitalis purpurea Glaucarubin Amoebicide Simarouba glauca Glaucine Antitussive Glaucium flavum Glasiovine Antidepressant Octea glaziovii Glycyrrhizin Sweetener, Addison's disease Glycyrrhiza glabra Gossypol Male contraceptive Gossypium species Hemsleyadin Bacillary dysentery Hemsleya amabilis Hesperidin Capillary fragility Citrus species
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Hyoscyamine Anticholinergic Hyoscyamus niger Irinotecan Anticancer, antitumor agent Camptotheca acuminata Kaibic acud Ascaricide Digenea simplex Kawain Tranquillizer Piper methysticum Kheltin Bronchodilator Ammi visaga Lanatosides A, B, C Cardiotonic Digitalis lanata Lapachol Anticancer, antitumor Tabebuia sp. a-Lobeline Smoking deterrant, respiratory stimulant Lobelia inflata Menthol Rubefacient Mentha species Methyl salicylate Rubefacient Gaultheria procumbens
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Monocrotaline Antitumor agent (topical) Crotalaria sessiliflora Morphine Analgesic Papaver somniferum Neoandrographolide Dysentery Andrographis paniculata Nicotine Insecticide Nicotiana tabacum Nordihydroguaiaretic acid Antioxidant Larrea divaricata Noscapine Antitussive Papaver somniferum Ouabain Cardiotonic Strophanthus gratus Pachycarpine Oxytocic Sophora pschycarpa Palmatine Antipyretic, detoxicant Coptis japonica Papain Proteolytic, mucolytic Carica papaya
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Qulsqualic acid Anthelmintic Quisqualis indica Rescinnamine Antihypertensive, tranquillizer Rauvolfia serpentina Reserpine Antihypertensive, tranquillizer Rauvolfia serpentina Rhomitoxin Antihypertensive, tranquillizer Rhododendron molle Rorifone Antitussive Rorippa indica Rotenone Piscicide, Insecticide Lonchocarpus nicou Rotundine Analagesic, sedative, traquillizer Stephania sinica Rutin Capillary fragility Citrus species
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Salicin Analgesic Salix alba Sanguinarine Dental plaque inhibitor Sanguinaria canadensis Santonin Ascaricide Artemisia maritma Scillarin A Cardiotonic Urginea maritima Scopolamine Sedative Datura species Sennosides A, B Laxative Cassia species Silymarin Antihepatotoxic Silybum marianum Sparteine Oxytocic Cytisus scoparius Stevioside Sweetner Stevia rebaudiana Strychnine CNS stimulant Strychnos nux-vomica
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Taxol Antitumor agent Taxus brevifolia Teniposide Antitumor agent Podophyllum peltatum a-Tetrahydrocannabinol(THC) Antiemetic, decrease occular tension Cannabis sativa Tetrahydropalmatine Analgesic, sedative, traquillizer Corydalis ambigua Tetrandrine Antihypertensive Stephania tetrandra Theobromine Diuretic, vasodilator Theobroma cacao Theophylline Diuretic, brochodilator Theobroma cacao and others Thymol Antifungal (topical) Thymus vulgaris
01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Topotecan Antitumor, anticancer agent Camptotheca acuminata Trichosanthin Abortifacient Trichosanthes kirilowii Tubocurarine Skeletal muscle relaxant Chondodendron tomentosum Valapotriates Sedative Valeriana officinalis Vasicine Cerebral stimulant Vinca minor Vinblastine Antitumor, Antileukemic agent Catharanthus roseus Vincristine Antitumor, Antileukemic agent Catharanthus roseus Yohimbine Aphrodisiac Pausinystalia yohimbe Yuanhuacine Abortifacient Daphne genkwa Yuanhuadine Abortifacient Daphne genkwa
01/03/2011 DUHS-Pharma Envir Res Lab The New Drug Development Process (Steps from Test Tube to New Drug Application Review)
[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Non-clinical Drug Development
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Non-clinical Drug Development
[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Non-clinical Drug Development
FDA will generally ask ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Subpart E
[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Sponsor/FDA Meetings ( Pre-IND)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Synthesis and Purification
[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Animal Testing
Short and Long Term Animal Testing ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Institutional Review Board ,[object Object],[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
IND Submitted ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],IND Submitted 01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],[object Object],[object Object],IND Submitted 01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],[object Object],IND Submitted 01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],[object Object],IND Submitted 01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],[object Object],[object Object],[object Object],IND Submitted 01/03/2011 DUHS-Pharma Envir Res Lab
Phase 1 Clinical Studies ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Phase 1 Clinical Studies
Phase 2 Clinical Studies ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Sponsor/FDA Meeting (End of Phase 2) ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Phase 3 Clinical Studies
[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab Phase 3 Clinical Studies
Accelerated Development/ Review ,[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Treatment IND ,[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
Long – Term Testing ,[object Object],[object Object],[object Object],[object Object],01/03/2011 DUHS-Pharma Envir Res Lab
01/03/2011 DUHS-Pharma Envir Res Lab IND Review Process
01/03/2011 DUHS-Pharma Envir Res Lab NDA Review Process
01/03/2011 DUHS-Pharma Envir Res Lab Generic Drug (ANDA) Review Process
01/03/2011 DUHS-Pharma Envir Res Lab OTC Drug Monograph Review Process
01/03/2011 DUHS-Pharma Envir Res Lab Thank you for.....

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Clinical trials and drug discovery & development 01-03-2011

  • 1. CLINICAL TRIALS: DRUG DISCOVERY – NEW DRUG DEVELOPMENT PROCESS BY Dr. M. Rafiq Khanani Associate Professor, Pathology, Dow International Medical College Director, Dow Diagnostic Reference & Research Lab Dow University of Health Sciences (DUHS) President, Infection Control Society Pakistan Pathologist Citilab Email: [email_address] , [email_address] www.duhs.edu.pk : www.infectioncontrolsociety.org
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  • 14. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Acetyldigoxin Cardiotonic Digitalis lanata Adoniside Cardiotonic Adonis vernalis Aescin Anti-inflammatory Aesculus hippocastanum Aesculetin Anti-dysentery Frazinus rhychophylla Agrimophol Anthelmintic Agrimonia supatoria Ajmalicine Circulatory Disorders Rauvolfia sepentina Allantoin Vulnerary Several plants Allyl isothiocyanate Rubefacient Brassica nigra Anabesine Skeletal muscle relaxant Anabasis sphylla Andrographolide Baccillary dysentery Andrographis paniculata Anisodamine Anticholinergic Anisodus tanguticus
  • 15. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Anisodine Anticholinergic Anisodus tanguticus Arecoline Anthelmintic Areca catechu Asiaticoside Vulnerary Centella asiatica Atropine Anticholinergic Atropa belladonna Benzyl benzoate Scabicide Several plants Berberine Bacillary dysentery Berberis vulgaris Bergenin Antitussive Ardisia japonica Betulinic acid Anticancerous Betula alba Borneol Antipyretic, analgesic, antiinflammatory Several plants Bromelain Anti-inflammatory, proteolytic Ananas comosus Caffeine CNS stimulant Camellia sinensis
  • 16. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Cynarin Choleretic Cynara scolymus Danthron Laxative Cassia species Demecolcine Antitumor agent Colchicum autumnale Deserpidine Antihypertensive, tranquillizer Rauvolfia canescens Deslanoside Cardiotonic Digitalis lanata L-Dopa Anti-parkinsonism Mucuna sp Digitalin Cardiotonic Digitalis purpurea Digitoxin Cardiotonic Digitalis purpurea Digoxin Cardiotonic Digitalis purpurea Emetine Amoebicide, emetic Cephaelis ipecacuanha Ephedrine
  • 17. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Etoposide Antitumor agent Podophyllum peltatum Galanthamine Cholinesterase inhibitor Lycoris squamigera Gitalin Cardiotonic Digitalis purpurea Glaucarubin Amoebicide Simarouba glauca Glaucine Antitussive Glaucium flavum Glasiovine Antidepressant Octea glaziovii Glycyrrhizin Sweetener, Addison's disease Glycyrrhiza glabra Gossypol Male contraceptive Gossypium species Hemsleyadin Bacillary dysentery Hemsleya amabilis Hesperidin Capillary fragility Citrus species
  • 18. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Hyoscyamine Anticholinergic Hyoscyamus niger Irinotecan Anticancer, antitumor agent Camptotheca acuminata Kaibic acud Ascaricide Digenea simplex Kawain Tranquillizer Piper methysticum Kheltin Bronchodilator Ammi visaga Lanatosides A, B, C Cardiotonic Digitalis lanata Lapachol Anticancer, antitumor Tabebuia sp. a-Lobeline Smoking deterrant, respiratory stimulant Lobelia inflata Menthol Rubefacient Mentha species Methyl salicylate Rubefacient Gaultheria procumbens
  • 19. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Monocrotaline Antitumor agent (topical) Crotalaria sessiliflora Morphine Analgesic Papaver somniferum Neoandrographolide Dysentery Andrographis paniculata Nicotine Insecticide Nicotiana tabacum Nordihydroguaiaretic acid Antioxidant Larrea divaricata Noscapine Antitussive Papaver somniferum Ouabain Cardiotonic Strophanthus gratus Pachycarpine Oxytocic Sophora pschycarpa Palmatine Antipyretic, detoxicant Coptis japonica Papain Proteolytic, mucolytic Carica papaya
  • 20. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Qulsqualic acid Anthelmintic Quisqualis indica Rescinnamine Antihypertensive, tranquillizer Rauvolfia serpentina Reserpine Antihypertensive, tranquillizer Rauvolfia serpentina Rhomitoxin Antihypertensive, tranquillizer Rhododendron molle Rorifone Antitussive Rorippa indica Rotenone Piscicide, Insecticide Lonchocarpus nicou Rotundine Analagesic, sedative, traquillizer Stephania sinica Rutin Capillary fragility Citrus species
  • 21. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Salicin Analgesic Salix alba Sanguinarine Dental plaque inhibitor Sanguinaria canadensis Santonin Ascaricide Artemisia maritma Scillarin A Cardiotonic Urginea maritima Scopolamine Sedative Datura species Sennosides A, B Laxative Cassia species Silymarin Antihepatotoxic Silybum marianum Sparteine Oxytocic Cytisus scoparius Stevioside Sweetner Stevia rebaudiana Strychnine CNS stimulant Strychnos nux-vomica
  • 22. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Taxol Antitumor agent Taxus brevifolia Teniposide Antitumor agent Podophyllum peltatum a-Tetrahydrocannabinol(THC) Antiemetic, decrease occular tension Cannabis sativa Tetrahydropalmatine Analgesic, sedative, traquillizer Corydalis ambigua Tetrandrine Antihypertensive Stephania tetrandra Theobromine Diuretic, vasodilator Theobroma cacao Theophylline Diuretic, brochodilator Theobroma cacao and others Thymol Antifungal (topical) Thymus vulgaris
  • 23. 01/03/2011 DUHS-Pharma Envir Res Lab Plant Based Drugs and Medicines Drug/Chemical Action/Clinical Use Plant Source Topotecan Antitumor, anticancer agent Camptotheca acuminata Trichosanthin Abortifacient Trichosanthes kirilowii Tubocurarine Skeletal muscle relaxant Chondodendron tomentosum Valapotriates Sedative Valeriana officinalis Vasicine Cerebral stimulant Vinca minor Vinblastine Antitumor, Antileukemic agent Catharanthus roseus Vincristine Antitumor, Antileukemic agent Catharanthus roseus Yohimbine Aphrodisiac Pausinystalia yohimbe Yuanhuacine Abortifacient Daphne genkwa Yuanhuadine Abortifacient Daphne genkwa
  • 24. 01/03/2011 DUHS-Pharma Envir Res Lab The New Drug Development Process (Steps from Test Tube to New Drug Application Review)
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  • 50. 01/03/2011 DUHS-Pharma Envir Res Lab IND Review Process
  • 51. 01/03/2011 DUHS-Pharma Envir Res Lab NDA Review Process
  • 52. 01/03/2011 DUHS-Pharma Envir Res Lab Generic Drug (ANDA) Review Process
  • 53. 01/03/2011 DUHS-Pharma Envir Res Lab OTC Drug Monograph Review Process
  • 54. 01/03/2011 DUHS-Pharma Envir Res Lab Thank you for.....