| Description |
1 online resource (x, 252 pages) |
| Contents |
Introduction / Elizabeth Kwong -- Lead identification/optimization / Dr. Mei Wong And Dr. Mark Mcallister -- Oral drug formulation development in pharmaceutical lead selection stage / Shayne Cox Gad -- Bridging end of discovery to regulatory filing : formulations for IND- and registration-enabling nonclinical studies / Evan A. Thackaberry -- Planning the first clinical trials with clinical manufacturing organization (CMO) / Elizabeth Kwong and Caroline McGregor -- Formulation strategies for high dose toxicology studies : case studies / Dennis H. Leung, Pierre Daublain, Mengwei Hu, Kung-I Feng -- Formulation, analytical and regulatory strategies for first in human clinical trials / Lorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden, and Steven Booth |
| Summary |
Detailing formulation approaches by stage of discovery to early development, this book gives a "playbook" of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry. Focuses on pre (or non- ) clinical and early stage development, the phases where most compounds are used in drug research. Features case studies to illustrate practical challenges and solutions in formulation selection. Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drug development.
|
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Drugs -- Dosage forms.
|
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Drug Discovery
|
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Chemistry, Pharmaceutical -- methods
|
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Clinical Trials as Topic
|
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Dosage Forms
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Administratoin, Oral
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Drugs -- Dosage forms.
|
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MEDICAL -- Pharmacology.
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Drug development.
|
| Form |
Electronic book
|
| Author |
Kwong, Elizabeth, 1954- editor.
|
| ISBN |
9781118907894 |
|
1118907892 |
|
9781118907870 |
|
1118907876 |
|
9781118908020 |
|
1118908023 |
|
9781118907955 |
|
1118907957 |
|
