March 2017

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Industry News

Draft Guidance for Industry: Referencing Approved Drug Products in Anda Submissions

Late January, the FDA published a draft guidance intended to help applicants who are submitting an abbreviated new drug application to identify the reference listed drug (RLD). The guidance, which pertains to generic drugs submitted under 505(j) of the FD&C Act, describes selecting the reference listed drug, or reference standard in some cases, as well as clearly defining what is considered the basis of submission. The guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.

 
VIEW THE GUIDANCE

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Ask the Experts

Do you have a question about your drug development program or a clinical trial? Get access to some of the industry's leading experts here.

Ingrid Holmes, Vice President, Clinical Operations

DRIVING SIMULATION

According to the FDA's draft guidance, all drugs, including those intended for non-CNS indications, should be tested for adverse effects on the CNS during first-in-human studies.

Then based on the accumulated clinical data from early clinical development, any drug with a potential for driving impairment, should have a dedicated driving study performed. As Vice President, Clinical Operations, Ingrid Holmes’ responsibilities include the oversight and smooth conduct of all driving simulation trials conducted at Altasciences.

We are experts in performing cognitive testing during all phases of clinical development, including dedicated driving studies to test the effects of drugs on driving abilities in both normal and patient populations.

Click below to ask a question of Ingrid.

Graham Wood, PhD, Executive Vice President, Phase I Clinical Development

MULTISITE STUDIES

Dr. Graham Wood, PhD, Executive Vice President, Phase I Clinical Development, is well versed in the management of multisite studies looking at clinical pharmacology or efficacy.

Our team of Project Managers (PMs) and Medical Science Liaisons are experts in running clinical pharmacology studies, either at one of our Altasciences sites, or at our three sites working together.

In addition to our three sites, we have a database of academic and independent investigator sites with whom we partner for larger studies or difficult to recruit populations. The PMs also tie in our medical writers, biostatisticians and data managers, allowing us to provide full service options for multicenter studies.

Click below to ask Dr. Wood a question.

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NDA SUBMISSION

We can design and conduct your clinical pharmacology studies from first-in-human trials, up to the complete package of NDA-enabling studies. We can help you prepare for the end of your Phase II meeting by designing the clinical pharmacology studies you will need to review with the regulatory agencies. Each study type has its own set of requirements, and its own design.

VOLUMETRIC ABSORPTIVE MICROSAMPLING

Dr. Keyhani’s presentation at SOT offered an introduction to concepts and techniques of VAMS microsampling in support of the bioanalytical phase of GLP-compliant studies, including case studies from method development, validation and sample analysis using VAMS.

CERTIFICATE OF ANALYSIS

On February 14th, Dr. Marie-Christine Lacasse presented a webinar in collaboration with the Society of Quality Assurance titled ‘Certificate of Analysis Essentials for Regulated Bioanalysis’. Proper understanding of the information on a certificate of analysis can prevent costly mistakes!

SEE HOW WE CAN HELP
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