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DRUG DISCOVERY – NEW DRUG DEVELOPMENT PROCESS BY Dr. BASAVARAJ K. NANJWADE Department of Pharmaceutics K L E  UNIVERSITY   JN MEDICAL COLLEGE BELGAUM – 590010 E-mail: bknanjwade@yahoo.co.in
[object Object],[object Object],DRUG
[object Object],[object Object],[object Object],Continued
[object Object],[object Object],[object Object],Continued
[object Object],[object Object],[object Object],Continued
[object Object],[object Object],[object Object],[object Object]
How Drugs are Developed   ,[object Object],[object Object]
Differences and Similarities of Drugs and Medicinal Plants ,[object Object],[object Object],[object Object]
Differences and Similarities of Drugs and Medicinal Plants ,[object Object],[object Object],[object Object],[object Object]
Need for consumer education about Herbal supplements & Drugs ,[object Object],[object Object]
More is Not Always Better ,[object Object],[object Object]
Problem of One Vs Several Chemicals ,[object Object],[object Object],[object Object],[object Object]
Plant Based Drugs and Medicines   Anisodus tanguticus Anticholinergic Anisodamine Andrographis paniculata Baccillary dysentery Andrographolide Anabasis sphylla Skeletal muscle relaxant Anabesine Brassica nigra Rubefacient Allyl isothiocyanate Several plants Vulnerary Allantoin Rauvolfia sepentina Circulatory Disorders Ajmalicine Agrimonia supatoria Anthelmintic Agrimophol Frazinus rhychophylla Anti-dysentery Aesculetin Aesculus hippocastanum Anti-inflammatory Aescin Adonis vernalis Cardiotonic Adoniside Digitalis lanata Cardiotonic Acetyldigoxin Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines  Camellia sinensis CNS stimulant Caffeine Ananas comosus Anti-inflammatory, proteolytic Bromelain Several plants Antipyretic, analgesic, antiinflammatory Borneol Betula alba Anticancerous Betulinic  acid Ardisia japonica Antitussive Bergenin Berberis vulgaris Bacillary dysentery Berberine Several plants Scabicide Benzyl benzoate Atropa belladonna Anticholinergic Atropine Centella asiatica Vulnerary Asiaticoside Areca catechu Anthelmintic Arecoline Anisodus tanguticus Anticholinergic Anisodine Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Curcuma  longa Choleretic Curcumin Convallaria majalis Cardiotonic Convallatoxin Colchicum  autumnale Antitumor agent, anti-gout Colchicine Colchicum  autumnale Antitumor agent Colchiceine  amide Papaver somniferum Analgesic, antitussive Codeine Erythroxylum coca Local anaesthetic Cocaine Cissampelos   pareira Skeletal muscle relaxant Cissampeline Carica  papaya Proteolytic, mucolytic Chymopapain Potentilla fragarioides Haemostatic (+)-Catechin Camptotheca   acuminata Anticancerous Camptothecin Cinnamomum camphora Rubefacient Camphor Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Ephedrine Cephaelis ipecacuanha Amoebicide, emetic Emetine Digitalis purpurea Cardiotonic Digoxin Digitalis purpurea Cardiotonic Digitoxin Digitalis purpurea Cardiotonic Digitalin Mucuna  sp Anti-parkinsonism L-Dopa Digitalis lanata Cardiotonic Deslanoside Rauvolfia canescens Antihypertensive, tranquillizer Deserpidine Colchicum autumnale Antitumor agent Demecolcine Cassia species Laxative Danthron Cynara   scolymus Choleretic Cynarin Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Citrus species Capillary fragility Hesperidin Hemsleya amabilis Bacillary dysentery Hemsleyadin Gossypium species Male contraceptive Gossypol Glycyrrhiza   glabra Sweetener, Addison's disease Glycyrrhizin Octea glaziovii Antidepressant Glasiovine Glaucium flavum Antitussive Glaucine Simarouba   glauca Amoebicide Glaucarubin Digitalis purpurea Cardiotonic Gitalin Lycoris squamigera Cholinesterase inhibitor Galanthamine Podophyllum   peltatum Antitumor agent Etoposide Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Gaultheria procumbens Rubefacient Methyl salicylate Mentha  species Rubefacient Menthol Lobelia inflata Smoking deterrant, respiratory stimulant a-Lobeline  Tabebuia  sp. Anticancer, antitumor Lapachol Digitalis lanata Cardiotonic Lanatosides A, B, C Ammi visaga Bronchodilator Kheltin Piper methysticum Tranquillizer Kawain Digenea simplex Ascaricide Kaibic acud Camptotheca   acuminata Anticancer, antitumor agent Irinotecan   Hyoscyamus niger Anticholinergic Hyoscyamine Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Carica  papaya Proteolytic, mucolytic Papain Coptis japonica Antipyretic, detoxicant Palmatine Sophora pschycarpa Oxytocic Pachycarpine Strophanthus gratus Cardiotonic Ouabain Papaver somniferum Antitussive Noscapine Larrea divaricata Antioxidant Nordihydroguaiaretic acid Nicotiana tabacum Insecticide Nicotine Andrographis paniculata Dysentery Neoandrographolide Papaver somniferum Analgesic Morphine Crotalaria sessiliflora Antitumor agent (topical) Monocrotaline Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Cinchona  ledgeriana Antiarrhythmic Quinidine Ephedra sinica Sympathomimetic Pseudoephedrine, nor-  Ephedra sinica Sympathomimetic Pseudoephredrine* Veratrum album Antihypertensives Protoveratrines A, B Podophyllum   peltatum Antitumor anticancer agent Podophyllotoxin Several plants Expectorant Pinitol Pilocarpus  jaborandi Parasympathomimetic Pilocarpine Anamirta cocculus Analeptic Picrotoxin Physostigma venenosum Cholinesterase Inhibitor Physostigmine Hydrangea macrophylla Sweetner Phyllodulcin Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Citrus species Capillary fragility Rutin Stephania sinica Analagesic, sedative, traquillizer Rotundine Lonchocarpus nicou Piscicide, Insecticide Rotenone Rorippa indica Antitussive Rorifone Rhododendron molle Antihypertensive, tranquillizer Rhomitoxin Rauvolfia serpentina Antihypertensive, tranquillizer Reserpine Rauvolfia serpentina Antihypertensive, tranquillizer Rescinnamine Quisqualis indica Anthelmintic Qulsqualic acid Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Strychnos nux-vomica CNS stimulant Strychnine Stevia   rebaudiana Sweetner Stevioside Cytisus scoparius Oxytocic Sparteine Silybum marianum Antihepatotoxic Silymarin Cassia species Laxative Sennosides A, B Datura species Sedative Scopolamine Urginea maritima Cardiotonic Scillarin A Artemisia maritma Ascaricide Santonin Sanguinaria canadensis Dental plaque inhibitor Sanguinarine Salix alba Analgesic Salicin Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Thymus vulgaris Antifungal (topical) Thymol Theobroma  cacao and others Diuretic, brochodilator Theophylline Theobroma  cacao Diuretic, vasodilator Theobromine Stephania tetrandra Antihypertensive Tetrandrine Corydalis ambigua Analgesic, sedative, traquillizer Tetrahydropalmatine Cannabis sativa Antiemetic, decrease occular tension a- Tetrahydrocannabinol (THC) Podophyllum   peltatum Antitumor agent Teniposide Taxus   brevifolia Antitumor agent Taxol Plant Source Action/Clinical Use Drug/Chemical
Plant Based Drugs and Medicines   Daphne genkwa Abortifacient Yuanhuadine Daphne genkwa Abortifacient Yuanhuacine Pausinystalia yohimbe Aphrodisiac Yohimbine Catharanthus   roseus Antitumor, Antileukemic agent Vincristine Catharanthus   roseus Antitumor, Antileukemic agent Vinblastine Vinca  minor Cerebral stimulant Vasicine Valeriana officinalis Sedative Valapotriates Chondodendron   tomentosum Skeletal muscle relaxant Tubocurarine Trichosanthes   kirilowii Abortifacient Trichosanthin Camptotheca   acuminata Antitumor, anticancer agent Topotecan   Plant Source Action/Clinical Use Drug/Chemical
The New Drug Development Process   (Steps from Test Tube to New Drug Application Review)
[object Object],[object Object],Non-clinical Drug Development
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Non-clinical Drug Development
[object Object],[object Object],Non-clinical Drug Development
FDA will generally ask ,[object Object],[object Object],[object Object]
[object Object],Subpart E
[object Object],[object Object],[object Object],Sponsor/FDA Meetings ( Pre-IND)
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Synthesis and Purification
[object Object],[object Object],[object Object],Animal Testing
Short and Long Term  Animal Testing ,[object Object],[object Object],[object Object]
Institutional Review Board ,[object Object],[object Object],[object Object],[object Object],[object Object]
IND Submitted ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],IND Submitted
[object Object],[object Object],[object Object],[object Object],IND Submitted
[object Object],[object Object],[object Object],IND Submitted
[object Object],[object Object],[object Object],IND Submitted
[object Object],[object Object],[object Object],[object Object],[object Object],IND Submitted
Phase 1 Clinical Studies ,[object Object],[object Object],[object Object]
[object Object],[object Object],Phase 1 Clinical Studies
Phase 2 Clinical Studies ,[object Object],[object Object],[object Object]
Sponsor/FDA Meeting (End of Phase 2) ,[object Object],[object Object],[object Object]
[object Object],[object Object],Phase 3 Clinical Studies
[object Object],[object Object],[object Object],Phase 3 Clinical Studies
Accelerated Development/ Review ,[object Object],[object Object],[object Object]
Treatment  IND   ,[object Object],[object Object],[object Object],[object Object]
Long – Term Testing ,[object Object],[object Object],[object Object],[object Object]
IND Review Process
NDA Review Process
Generic Drug (ANDA) Review Process
OTC Drug Monograph Review Process
Thank you for.....

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Drug Discovery New Drug Development Process

  • 1. DRUG DISCOVERY – NEW DRUG DEVELOPMENT PROCESS BY Dr. BASAVARAJ K. NANJWADE Department of Pharmaceutics K L E  UNIVERSITY JN MEDICAL COLLEGE BELGAUM – 590010 E-mail: bknanjwade@yahoo.co.in
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  • 13. Plant Based Drugs and Medicines Anisodus tanguticus Anticholinergic Anisodamine Andrographis paniculata Baccillary dysentery Andrographolide Anabasis sphylla Skeletal muscle relaxant Anabesine Brassica nigra Rubefacient Allyl isothiocyanate Several plants Vulnerary Allantoin Rauvolfia sepentina Circulatory Disorders Ajmalicine Agrimonia supatoria Anthelmintic Agrimophol Frazinus rhychophylla Anti-dysentery Aesculetin Aesculus hippocastanum Anti-inflammatory Aescin Adonis vernalis Cardiotonic Adoniside Digitalis lanata Cardiotonic Acetyldigoxin Plant Source Action/Clinical Use Drug/Chemical
  • 14. Plant Based Drugs and Medicines Camellia sinensis CNS stimulant Caffeine Ananas comosus Anti-inflammatory, proteolytic Bromelain Several plants Antipyretic, analgesic, antiinflammatory Borneol Betula alba Anticancerous Betulinic acid Ardisia japonica Antitussive Bergenin Berberis vulgaris Bacillary dysentery Berberine Several plants Scabicide Benzyl benzoate Atropa belladonna Anticholinergic Atropine Centella asiatica Vulnerary Asiaticoside Areca catechu Anthelmintic Arecoline Anisodus tanguticus Anticholinergic Anisodine Plant Source Action/Clinical Use Drug/Chemical
  • 15. Plant Based Drugs and Medicines Curcuma longa Choleretic Curcumin Convallaria majalis Cardiotonic Convallatoxin Colchicum autumnale Antitumor agent, anti-gout Colchicine Colchicum autumnale Antitumor agent Colchiceine amide Papaver somniferum Analgesic, antitussive Codeine Erythroxylum coca Local anaesthetic Cocaine Cissampelos pareira Skeletal muscle relaxant Cissampeline Carica papaya Proteolytic, mucolytic Chymopapain Potentilla fragarioides Haemostatic (+)-Catechin Camptotheca acuminata Anticancerous Camptothecin Cinnamomum camphora Rubefacient Camphor Plant Source Action/Clinical Use Drug/Chemical
  • 16. Plant Based Drugs and Medicines Ephedrine Cephaelis ipecacuanha Amoebicide, emetic Emetine Digitalis purpurea Cardiotonic Digoxin Digitalis purpurea Cardiotonic Digitoxin Digitalis purpurea Cardiotonic Digitalin Mucuna sp Anti-parkinsonism L-Dopa Digitalis lanata Cardiotonic Deslanoside Rauvolfia canescens Antihypertensive, tranquillizer Deserpidine Colchicum autumnale Antitumor agent Demecolcine Cassia species Laxative Danthron Cynara scolymus Choleretic Cynarin Plant Source Action/Clinical Use Drug/Chemical
  • 17. Plant Based Drugs and Medicines Citrus species Capillary fragility Hesperidin Hemsleya amabilis Bacillary dysentery Hemsleyadin Gossypium species Male contraceptive Gossypol Glycyrrhiza glabra Sweetener, Addison's disease Glycyrrhizin Octea glaziovii Antidepressant Glasiovine Glaucium flavum Antitussive Glaucine Simarouba glauca Amoebicide Glaucarubin Digitalis purpurea Cardiotonic Gitalin Lycoris squamigera Cholinesterase inhibitor Galanthamine Podophyllum peltatum Antitumor agent Etoposide Plant Source Action/Clinical Use Drug/Chemical
  • 18. Plant Based Drugs and Medicines Gaultheria procumbens Rubefacient Methyl salicylate Mentha species Rubefacient Menthol Lobelia inflata Smoking deterrant, respiratory stimulant a-Lobeline Tabebuia sp. Anticancer, antitumor Lapachol Digitalis lanata Cardiotonic Lanatosides A, B, C Ammi visaga Bronchodilator Kheltin Piper methysticum Tranquillizer Kawain Digenea simplex Ascaricide Kaibic acud Camptotheca acuminata Anticancer, antitumor agent Irinotecan Hyoscyamus niger Anticholinergic Hyoscyamine Plant Source Action/Clinical Use Drug/Chemical
  • 19. Plant Based Drugs and Medicines Carica papaya Proteolytic, mucolytic Papain Coptis japonica Antipyretic, detoxicant Palmatine Sophora pschycarpa Oxytocic Pachycarpine Strophanthus gratus Cardiotonic Ouabain Papaver somniferum Antitussive Noscapine Larrea divaricata Antioxidant Nordihydroguaiaretic acid Nicotiana tabacum Insecticide Nicotine Andrographis paniculata Dysentery Neoandrographolide Papaver somniferum Analgesic Morphine Crotalaria sessiliflora Antitumor agent (topical) Monocrotaline Plant Source Action/Clinical Use Drug/Chemical
  • 20. Plant Based Drugs and Medicines Cinchona ledgeriana Antiarrhythmic Quinidine Ephedra sinica Sympathomimetic Pseudoephedrine, nor- Ephedra sinica Sympathomimetic Pseudoephredrine* Veratrum album Antihypertensives Protoveratrines A, B Podophyllum peltatum Antitumor anticancer agent Podophyllotoxin Several plants Expectorant Pinitol Pilocarpus jaborandi Parasympathomimetic Pilocarpine Anamirta cocculus Analeptic Picrotoxin Physostigma venenosum Cholinesterase Inhibitor Physostigmine Hydrangea macrophylla Sweetner Phyllodulcin Plant Source Action/Clinical Use Drug/Chemical
  • 21. Plant Based Drugs and Medicines Citrus species Capillary fragility Rutin Stephania sinica Analagesic, sedative, traquillizer Rotundine Lonchocarpus nicou Piscicide, Insecticide Rotenone Rorippa indica Antitussive Rorifone Rhododendron molle Antihypertensive, tranquillizer Rhomitoxin Rauvolfia serpentina Antihypertensive, tranquillizer Reserpine Rauvolfia serpentina Antihypertensive, tranquillizer Rescinnamine Quisqualis indica Anthelmintic Qulsqualic acid Plant Source Action/Clinical Use Drug/Chemical
  • 22. Plant Based Drugs and Medicines Strychnos nux-vomica CNS stimulant Strychnine Stevia rebaudiana Sweetner Stevioside Cytisus scoparius Oxytocic Sparteine Silybum marianum Antihepatotoxic Silymarin Cassia species Laxative Sennosides A, B Datura species Sedative Scopolamine Urginea maritima Cardiotonic Scillarin A Artemisia maritma Ascaricide Santonin Sanguinaria canadensis Dental plaque inhibitor Sanguinarine Salix alba Analgesic Salicin Plant Source Action/Clinical Use Drug/Chemical
  • 23. Plant Based Drugs and Medicines Thymus vulgaris Antifungal (topical) Thymol Theobroma cacao and others Diuretic, brochodilator Theophylline Theobroma cacao Diuretic, vasodilator Theobromine Stephania tetrandra Antihypertensive Tetrandrine Corydalis ambigua Analgesic, sedative, traquillizer Tetrahydropalmatine Cannabis sativa Antiemetic, decrease occular tension a- Tetrahydrocannabinol (THC) Podophyllum peltatum Antitumor agent Teniposide Taxus brevifolia Antitumor agent Taxol Plant Source Action/Clinical Use Drug/Chemical
  • 24. Plant Based Drugs and Medicines Daphne genkwa Abortifacient Yuanhuadine Daphne genkwa Abortifacient Yuanhuacine Pausinystalia yohimbe Aphrodisiac Yohimbine Catharanthus roseus Antitumor, Antileukemic agent Vincristine Catharanthus roseus Antitumor, Antileukemic agent Vinblastine Vinca minor Cerebral stimulant Vasicine Valeriana officinalis Sedative Valapotriates Chondodendron tomentosum Skeletal muscle relaxant Tubocurarine Trichosanthes kirilowii Abortifacient Trichosanthin Camptotheca acuminata Antitumor, anticancer agent Topotecan Plant Source Action/Clinical Use Drug/Chemical
  • 25. The New Drug Development Process (Steps from Test Tube to New Drug Application Review)
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  • 53. Generic Drug (ANDA) Review Process
  • 54. OTC Drug Monograph Review Process