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2009, 5th ed., Drugs and the pharmaceutical sciences, ISBN 9781420088496, Volume 190, xviii, 529
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval... 
Drugs | standards | Gevernment policy | Drug Evaluation | Clinical Trials as Topic | New products | Drug approval | Government policy | Testing | Clinical Trials - Pharmaceutical Science | Pharmaceutical Science Regulatory | Drug Design & Development
Book
2004, Drugs and the pharmaceutical sciences, ISBN 9780824754655, Volume 141., xix, 596
Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand... 
Drugs | Technology, pharmaceutical | Drug approval | Government policy | Standards | Testing | Pharmaceutical Science Regulatory | Drug Design & Development | Drug development
Book
Transfusion, ISSN 0041-1132, 12/2017, Volume 57, Issue 12, pp. 2836 - 2844
BACKGROUNDLaboratory and clinical evidence suggest that cold‐stored platelets (CS‐PLTs) might be preferable to room temperature platelets (RT‐PLTs) for active... 
Regulatory agencies | Agitation | Food contamination | Shelf life | FDA approval | Cold storage | Patients | Trauma | Bleeding | Clotting | Risk factors | Regulatory approval | Storage | Bacteria | Platelets | Ambulances
Journal Article
2008, 2nd ed., Drugs and the pharmaceutical sciences, ISBN 0849391849, Volume 181, x, 278
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection... 
Drugs | standards | United States. Food and Drug Administration | Laboratories | Drug Industry | Drug Approval | Research | Pharmaceutical Science Regulatory | Drug Design & Development | Analysis & Pharmaceutical Quality | United States | Food and Drug Administration | Standards
Book
JAMA, ISSN 0098-7484, 11/2017, Volume 318, Issue 19, pp. 1861 - 1862
Approval of the drug tisagenledeucel (Kymriah; Novartis) by the US Food and Drug Administration (FDA) for the treatment of pediatric and young adult acute... 
MEDICINE, GENERAL & INTERNAL | Regulatory agencies | Reminder | Acute lymphatic leukemia | Revenues | Leukemia | Norms | Oncology | FDA approval | Lymphatic leukemia | Cancer therapies | Patients | Cancer
Journal Article
Clinical Cancer Research, ISSN 1078-0432, 06/2017, Volume 23, Issue 12, pp. 2924 - 2927
Journal Article
Drugs, ISSN 0012-6667, 1/2018, Volume 78, Issue 1, pp. 139 - 145
Acerta Pharma is developing the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence®) for the treatment of various haematological and solid... 
Pharmacotherapy | Internal Medicine | Medicine & Public Health | Pharmacology/Toxicology | CHRONIC LYMPHOCYTIC-LEUKEMIA | PHARMACOLOGY & PHARMACY | TOXICOLOGY | Protein-Tyrosine Kinases - metabolism | United States | Humans | Pyrazines - administration & dosage | Antineoplastic Agents - therapeutic use | Drug Approval | Pyrazines - therapeutic use | Antineoplastic Agents - administration & dosage | Protein Kinase Inhibitors - adverse effects | Dose-Response Relationship, Drug | Benzamides - administration & dosage | Benzamides - therapeutic use | Antineoplastic Agents - adverse effects | Adult | Antineoplastic Agents - pharmacology | Benzamides - pharmacology | United States Food and Drug Administration | Antibodies, Monoclonal, Humanized - therapeutic use | Lymphoma, Mantle-Cell - drug therapy | Treatment Outcome | Protein Kinase Inhibitors - administration & dosage | Protein Kinase Inhibitors - therapeutic use | Agammaglobulinaemia Tyrosine Kinase | Protein Kinase Inhibitors - pharmacology | Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy | Pyrazines - pharmacology | Protein-Tyrosine Kinases - antagonists & inhibitors | Drug therapy | Care and treatment | Mantle cell lymphoma | Tyrosine | Plasma | Regulatory agencies | Phosphorylation | Chronic lymphatic leukemia | Hematology | Leukemia | Metastasis | FDA approval | Kinases | Cancer therapies | Lymphoma | Bruton's tyrosine kinase | Response rates | Lymphomas | Mantle | Drug dosages | Protein-tyrosine kinase | Pharmaceuticals
Journal Article
Drugs, ISSN 0012-6667, 2/2019, Volume 79, Issue 3, pp. 325 - 329
Journal Article
Drugs, ISSN 0012-6667, 4/2019, Volume 79, Issue 5, pp. 573 - 578
Toripalimab, a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed... 
Pharmacotherapy | Internal Medicine | Medicine & Public Health | Pharmacology/Toxicology | EFFICACY | PHARMACOLOGY & PHARMACY | TOXICOLOGY | Flow cytometry | PD-1 protein | Melanoma | Clinical trials | Breast cancer | Metastasis | Regulatory approval | Skin cancer | Metastases | Studies | Collaboration | PD-L1 protein | Monoclonal antibodies | Ligands | Agreements | Mutation | Recombinant | Pharmaceuticals | Tumors
Journal Article
Journal Article
Drugs, ISSN 0012-6667, 02/2019, Volume 79, Issue 2, pp. 215 - 220
Journal Article
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, ISSN 0098-7484, 01/2018, Volume 319, Issue 1, pp. 14 - 14
The first drug in the US that contains a sensor to track whether patients take their medication has received the Food and Drug Administration (FDA) approval.... 
MEDICINE, GENERAL & INTERNAL | Drugs | Regulatory agencies | Neuroleptics | Mental disorders | Schizophrenia | FDA approval | Sensors | Mental depression | Aripiprazole
Journal Article
Cancer Treatment Reviews, ISSN 0305-7372, 2010, Volume 36, Issue 6, pp. 458 - 467
Journal Article