Chemistry-manufacturing-control clinical trials

Table 2 Chemistry-Manufacturing-Control Considerations for National Center for Complementary and Alternative Medicine Clinical Trials...

Information amendments Submitted to report new information that would not be included as a protocol amendment or safety report. Examples include the results of animal testing, chemistry, manufacturing, and controls data, reports of completed or discontinued clinical trials, or changes in administrative information. 

The results of the preclinical and clinical trials and all manufacturing, chemistry, quality control, and test methods data are submitted to FDA in the form of a new drug application (NDA) or a biologies license application (BLA) for marketing approval. 

Having said this, as drug development proceeds and as the scale or production is changed from the pilot-scale production appropriate for the limited initial clinical investigations to the larger-scale production needed for expanded clinical trials, the sponsor should submit information amendments to update the initial information submitted on the chemistry, manufacturing, and control processes with information appropriate to the expanded scope of the investigation. 

Preclinical trials stage II Pharmacokinetics (absorption, distribution, metabolism, and excretion), subchronic toxicity, teratogenicity, mutagenicity, scale-up of synthesis, development of final dosage form, and production of clinical samples [Chemistry, Manufacturing, and Control (CMC) section for FDA],... 

Overview of Chemistry, Manufacturing, and Control Evidence Needed to Support Clinical Trials for Botanical Drugs... 

---