IND-Enabling

Investigational New Drug (IND) is the key milestone prior to clinical testing on humans. Development of IND-enabling technologies is crucial for accelerate the discovery of new drugs and significantly reduce time to market and safety profile issues. If the application is cleared, the candidate drug usually enters the clinical trial stages.

The IND application to FDA (Food and Drug Administration) must contain information in three broad areas:

  • Animal pharmacology and toxicology studies
  • Chemistry and manufacturing information
  • Clinical protocols and investigator information

Creative Biolabs offers comprehensive IND-enabling programs to assure that research subjects will not be subjected to unreasonable risks. Following the selection of clinical drug candidate criteria, we can help you with a number of preclinical IND-enabling studies and submitted the results in an IND application for approval to clinical phage trials.

We have years of IND research experience. The services of our highly cost-effective IND program include diverse fully validated IND-enabling studies consistent with appropriate positive and negative controls. These are conducted under Good Documentation Practices (GDP), and full submission-ready reports are provided. Our best-in-class experts will work closely with you to help your IND-enabling program from start to finish.

As part of our drug discovery and development system, we provide several services, which include in vivo toxicity, pre-formulation and formulation development, dose prediction and drug abuse tests which are routinely included in IND submissions. These studies are recommended by regulatory agencies, and they can provide valuable chemistry and manufacturing information and give advice in the design of future clinical studies.

Toxicity and Safety Evaluation

We provide a series of toxicology study services for preclinical toxicity evaluation. With extensive knowledge, we could offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicology studies can be conducted in multiple animal species.

Pre-formulation Development

We conduct pre-formulation studies to guide the formulation strategy for your drug candidate. Typical pre-formulation studies of pharmaceuticals include Physicochemical Characterization, Salt Selection, Polymorphism Screening, Compatibility Studies and Excipients Selection.

Formulation Development

Formulation development can play a significant role in providing maximum exposure of your drug candidate. Creative Biolabs brings the world-class equipment, facilities and highly dedicated formulation specialists to help you arrive at the optimal dosage form for your drug candidate. The forms we developed are scalable, high-quality and able to be commercialized.

Human Dose Prediction

Creative Biolabs validates human dose combined with in vitro, in silico and in vivo methods. We are able to predict human dose and Cmax for new drugs. Besides, risks in early human dose are able to rank, identify, and flag.

Process and Scale-up

We can understand the ultimate goal of your drug discovery project and the challenges you face in moving from lead optimization to preclinical research. Our team is able to carry out process and scale-up chemistry, and help you with a smooth transition from discovery into pre-clinical development, and subsequent GMP manufacture.

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Contact Us

USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
Fax: 1-631-207-8356
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