CLOSE

Specials

I agree We use cookies on this website to enhance your user experience. By clicking any link on this page you are giving your consent for us to set cookies. More info

Skip to: Curated Story Group 1
lifesciencesreview
US
EUROPE
APAC
LATAM
  • Home
  • Contributors
  • News
  • Conferences
  • Newsletter
  • Whitepapers
  • Magazine
  • About
×
#

Life Science Review Weekly Brief

Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Life Science Review

Subscribe

loading

Thank you for Subscribing to Life Science Review Weekly Brief

  • Home
  • News

Recommended picks

Critical Bioanalytical Challenges of ADCs

Critical Bioanalytical Challenges of...

The Importance of Bioanalytical Method Validation

The Importance of Bioanalytical...

Korber Widens Its Werum PAS-X MES Service Partner Network

Korber Widens Its Werum PAS-X MES...

How New Regulations are Impacting the Life Science Sector

How New Regulations are Impacting the...

Significance of Bioanalytical Studies

Significance of Bioanalytical Studies

Invenio Genetics and Imagene Labs Announces Collaboration

Invenio Genetics and Imagene Labs...

Bioanalytical Testing Services and its Market

Bioanalytical Testing Services and...

Bradford Smith, Chief Financial Officer (CFO) of Homology Medicines Joins eGenesis as an independent director

Bradford Smith, Chief Financial...

Critical Bioanalytical Challenges of ADCs

Critical Bioanalytical Challenges of...

The Importance of Bioanalytical Method Validation

The Importance of Bioanalytical...

Korber Widens Its Werum PAS-X MES Service Partner Network

Korber Widens Its Werum PAS-X MES...

How New Regulations are Impacting the Life Science Sector

How New Regulations are Impacting the...

Significance of Bioanalytical Studies

Significance of Bioanalytical Studies

Invenio Genetics and Imagene Labs Announces Collaboration

Invenio Genetics and Imagene Labs...

Bioanalytical Testing Services and its Market

Bioanalytical Testing Services and...

Bradford Smith, Chief Financial Officer (CFO) of Homology Medicines Joins eGenesis as an independent director

Bradford Smith, Chief Financial...

Why Partner with Bioanalysis Experts?

Life Sciences Review | Thursday, August 12, 2021
Tweet

Bioanalytical studies are a key aspect of biologic drug development that may necessitate collaborating with bioanalysis experts.


FREMONT, CA: Today, it is widely accepted that bioanalysis is a vital part of the pharmacodynamic characterization of a novel chemical entity from the time of its discovery and during several stages of drug development, leading to its market authorization. The bioanalytical parameters and their application to drug discovery and development approaches will support the development of safe and more efficacious drugs with reduced development time and cost. Bioanalyses data are also an essential inclusion in regulatory filings, driving the demand for outsourcing partners with in-depth bioanalytical experience and experience interacting with regulatory authorities. Here is more about the need for partnering for bioanalytical studies.


Bioanalytical studies, which are tailored to offer estimates for the concentration of drugs and biologics in preclinical and clinical studies of the therapeutic molecule or their metabolites, are vital for several aspects of human clinical pharmacology, studies related to bioavailability evaluation, and some nonclinical studies needing concentration information for pharmacokinetics, toxicokinetics, or biomarkers. Bioanalytical work serves to supplement key studies and aid in the decision-making process for approval, safety, and/or labeling a drug or biologic. 


Without proper bioanalytical data, the therapeutic product would not be approved.


Beyond the regulatory needs for conducting bioanalytical studies, the importance of the data that these assays create is invaluable. Bioanalytical assays offer information on many safety aspects of the therapeutic in deciding the maximum tolerated dose. Pharmacokinetics use the information to decide exposure, half-life, and other pharmacological parameters, which are leveraged to guide decisions on how often and how much of a therapeutic should be given for efficacy without undue toxicity.


The requirement for sound bioanalytical methods is well understood in the discovery phase and during the preclinical and clinical stages of drug development. Therefore, it is accepted that sample preparation and method validation are needed to demonstrate the method's performance and the reliability of the analytical outcomes. The acceptance factor should be established in a validation plan before the initiation of the validation study. The developed assay should be rugged in that it offers opportunities for minor modifications to suit other bioanalytical requirements such as applicability to a drug–drug interaction study, toxicokinetic study, and characterization of the plasma levels of the metabolites.


Weekly Brief

loading
Top 10 Bioanalytical Service Companies in APAC - 2021
> <
  • Regulatory Services 2022

    Top Vendors

    Current Issue
  • Clinical Stage Biopharmaceutical 2022

    Top Vendors

    Current Issue
  • Clinical Trial Management 2022

    Top Vendors

    Current Issue
  • Clinical Trial Management 2022

    Top Vendors

    Current Issue
  • Regulatory Services 2022

    Top Vendors

    Current Issue
  • Clinical Stage Biopharmaceutical 2022

    Top Vendors

    Current Issue
  • Clinical Trial Management 2022

    Top Vendors

    Current Issue
  • Clinical Trial Management 2022

    Top Vendors

    Current Issue

Read Also

Everything You Need to Know About Medical Lab Equipment and their Applications

Everything You Need to Know About Medical Lab Equipment and their Applications

Lung Cancer patients can see improved results with Immunotherapy along with Chemotherapy Before surgery.

Lung Cancer patients can see improved results with Immunotherapy along with Chemotherapy Before surgery.

Here's The List Of Top Biotech Stocks To Buy In 2022

Here's The List Of Top Biotech Stocks To Buy In 2022

Efficacy and Safety Data by Entasis Therapeutics from Landmark Phase 3 Attack Trial

Efficacy and Safety Data by Entasis Therapeutics from Landmark Phase 3 Attack Trial
How Does Biotechnology Help Humans?

How Does Biotechnology Help Humans?

The several benefits Of Agricultural Genome Editing

The several benefits Of Agricultural Genome Editing

2027 Might See a Market Growth of Third-party Logistics at a CAGR of 7.1 percent

2027 Might See a Market Growth of Third-party Logistics at a CAGR of 7.1 percent

A Week To Celebrate The Significant Role Of Clinical Lab Professionals In Healthcare

A Week To Celebrate The Significant Role Of Clinical Lab Professionals In Healthcare
Loading...

Copyright © 2022 Life Science Review . All rights reserved. |  Subscribe |  About Us follow on linkedin

This content is copyright protected

However, if you would like to share the information in this article, you may use the link below:

https://www.lifesciencesreview.com/news/why-partner-with-bioanalysis-experts-nwid-266.html