Designing a molecular delivery system within a preclinical timeframe
An understanding of solid-state chemistry, including polymorphism, can reduce the time to filing an investigative new drug (IND) application. Obtaining a stable formulation for IND studies is crucial and must be the focus of much of the early solid-state chemistry research. Simple formulations such...
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| Veröffentlicht in: | Drug discovery today 2007-03, Vol.12 (5), p.189-199 |
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| container_title | Drug discovery today |
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| creator | Henck, Jan-Olav Byrn, Stephen R. |
| description | An understanding of solid-state chemistry, including polymorphism, can reduce the time to filing an investigative new drug (IND) application. Obtaining a stable formulation for IND studies is crucial and must be the focus of much of the early solid-state chemistry research. Simple formulations such as a chemical substance in capsule (CIC) – the chemical substance can be crystalline or amorphpous – are preferable for the IND trial and the solubility/dissolution rate has an important role in manufacturing IND clinical supplies. Two fast-to-IND flowcharts are presented here for exploratory IND and conventional IND. The utilization of quality by design and process analytical chemistry (PAT) concepts at an early stage will lay the foundation for the accelerated development of the medicines that are successful in the IND trials.
The field of solid-state chemistry of drugs encompasses many scientific disciplines and is crucial for preclinical drug development. |
| doi_str_mv | 10.1016/j.drudis.2007.01.006 |
| format | Article |
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The field of solid-state chemistry of drugs encompasses many scientific disciplines and is crucial for preclinical drug development.</description><subject>Biological and medical sciences</subject><subject>Chemistry Techniques, Analytical - methods</subject><subject>Crystallization</subject><subject>Drug Delivery Systems</subject><subject>Drug Design</subject><subject>Drug Evaluation, Preclinical - methods</subject><subject>Drug Stability</subject><subject>Drugs, Investigational</subject><subject>General pharmacology</subject><subject>Investigational New Drug Application - methods</subject><subject>Medical sciences</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. 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Pharmaceutical industry</topic><topic>Pharmacology. 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| identifier | ISSN: 1359-6446 |
| ispartof | Drug discovery today, 2007-03, Vol.12 (5), p.189-199 |
| issn | 1359-6446 1878-5832 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Biological and medical sciences Chemistry Techniques, Analytical - methods Crystallization Drug Delivery Systems Drug Design Drug Evaluation, Preclinical - methods Drug Stability Drugs, Investigational General pharmacology Investigational New Drug Application - methods Medical sciences Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Quality Control Software Design Solubility Technology, Pharmaceutical |
| title | Designing a molecular delivery system within a preclinical timeframe |
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