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Who are involved in filing investigational new drug applications

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use of analytical methods for drug quantification at many stages of drug development process grows in prevalence; the need for scientists, technicians, and quality assurance personnel, etc. to understand the complete validation process of the analytical method has become all the more important and necessary.

The validation of a method used is all the more important when it comes to dealing with quantitative analysis of drugs in various biological matrices such as blood, serum, plasma, cerebrospinal fluid, urine, tissues, etc. Yet, many companies overlook these crucial aspects of validation that are outlined in FDA's guidance, and end up receiving citations from this regulatory agency for these reasons. A company which receives these citations not only faces the prospect of delayed drug development; it can also dent and jeopardize the future of the drug's regulatory acceptance.

Clear understanding of FDA guidelines for bioanalytical method development and validation

A complete and clear understanding of the FDA guidelines for bioanalytical method development and validation is necessary to avoid being in situations outlined here. It is to familiarize pharmaceutical professionals with this important aspect of the FDA guidelines for bioanalytical method development and validation that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.

Venkata Kashyap Yellepeddi, who is an Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences, Utah and Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Utah; will be the speaker at this webinar. Please register for this webinar by visiting FDA guidelines for Bioanalytical

This webinar will offer intensive and detailed understanding of the bioanalytical method development and validation for drugs and nutraceuticals outlined in the FDA's guidance. This learning will add immense value to sponsors and analysts representing industries who are involved in filing any of the following:

o  Investigational new drug applications (INDs)

o  New drug applications (NDAs)

o  Abbreviated new drug applications (ANDAs)

o  Biologic license applications (BLAs)

o  Supplements in developing bioanalytical method validation information used in human clinical pharmacology

o  Bioavailability (BA)

o  Bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation

Analysts involved in bioanalytical methods used for nonclinical pharmacology/toxicology studies and for the veterinary drug approval process will also find this webinar highly valuable.

Matching the FDA’s level of expectations

The FDA expects anyone involved in quantification of drug using an analytical method in any stage of the drug development to be well-versed with FDA's guidance for bioanalytical method validation. With this assumption, FDA inspectors often ask questions on analytical method validation during routine inspections, and expect all personnel involved to be knowledgeable about the process of validation. This webinar will familiarize participants with these aspects of an FDA inspection.

Kash will cover the following specific areas during this webinar:

o  Chromatographic Methods

o  Ligand Binding Assays

o  Parameters involved in Bioanalytical Method Validation

o  Data Analysis, Statistics and Reporting

o  Additional issues in Bioanalytical Method Validation.

This course is of high value to those involved in one or another way with bioanalytical method development and validation, such as Chromatographers, Analysts, Chemists, Scientists, Formulators, Patent Lawyers, Technicians in Pharmaceutical and Veterinary Industry, and Contract Research Representatives.

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