Innovative Clinical Approach in Biosimilars

Clinical trials for biosimilars must exhibit practically identical security what's more, viability to the reference item, including consecutive PK/ PD and viability/security trials. Controllers expect PK/PD similarity information from a Phase I trial will bolster encourage viability/ wellbeing evaluations in crucial Phase III trials. Remain solitary Phase III investigations or joined Phase I/III outlines without supporting PK information are probably not going to be acknowledged. Clinical similarity prerequisites may fluctuate on a case-by-case premise subject to a risk based approach. Three-arm Phase I trials are progressively being used to show equivalence between the biosimilars and two authorized adaptations of a similar reference item that may exist in various markets, allowing developers to proceed with pivotal trials using a single version of the reference product

  • Biosimilars clinical trials
  • Clinical PK/PD studies
  • Toxicological studies
  • Risk management and quality affairs
  • Targeted cell line development
  • Case studies and clinical models
  • Biologics product life cycle and sustainable market returns

Related Conference of Innovative Clinical Approach in Biosimilars

October 05-06, 2020

International Congress on Drug Delivery

Auckland, Newzealand
October 15-16, 2020

nanomedicine-pharma-2020

Rome, Italy
October 21-22, 2020

20th Annual Meet on Pharmaceutical Sciences

Bangkok, Thailand
October 21-22, 2020

27th World Congress on Pharmacovigilance and Clinical Trials

Frankfurt, Germany
October 26-27, 2020

22nd International Conference on Drug Design and Development

Amsterdam, Netherlands
November 09-10, 2020

2nd World Congress on Drug Discovery and Drug Design

Tokyo, Japan
November 09-10, 2020

21st Global Summit on Analytical and Bioanlaytical Techniques

Amsterdam, Netherlands
November 9-10, 2020

Annual Meet on Pharmacovigilance & Drug Safety

Tokyo, Japan
November 09-10, 2020

20th Medicinal & Pharmaceutical Sciences Congress

Budapest, Hungary
November 09-10 , 2020

Asia Pacific Pharmaceutics & Drug Delivery Congress

| Tokyo , Japan
November 11-12, 2020

4th World Congress on Eye and Vision

Dubai, UAE
November 16-17, 2020

World Congress on Biologics and Biosimilars

Kyoto, Japan
November 19-20, 2020

Global summit on Cosmetic and Reconstructive Surgery

Tokyo, Japan
November 23-24, 2020

Pharma Expo China

Paris, France
November 23-24, 2020

Pharmaceutics & Novel Drug Delivery Summit China

Paris, France
November 23-24, 2020

21st Middle East PharmaTech & Expo

Istanbul, Turkey
November 25-26, 2020

8th World Congress on Antibiotics, Antimicrobials & Antibiotic Resistance

Singapore City, Singapore
November 26-27, 2020

11th World Congress on Bioavailability and Bioequivalence

Istanbul, Turkey
December 02-03, 2020

2nd International Conference on Bio-Pharmaceuticals

Auckland, Newzealand
December 07-08, 2020

International Liver Congress

Dubai, UAE
December 07-08, 2020

International Conference on Biotechnology and Healthcare

Auckland, Newzealand
January 22-23, 2021

1 st Global Summit on Generic Drugs and Quality Control

Prague, Czech Republic
January 22-23, 2021

1 st World Congress on Rare Diseases & Orphan Drugs

Prague, Czech Republic
February 26-27, 2021

2nd Annual Congress on Antibiotics and Bacterial Infections

Geneva, Switzerland
March 10-11, 2021

6th Pharmaceutical Chemistry Conference

Paris, France
April 28-29, 2021

31st Annual European Pharma Congress

London, UK
April 28-29, 2021

14th European Biosimilars Congress

London, UK
May 17-18, 2021

8th European Biopharma Congress

Prague, Czech Republic
May 19-20, 2021

36th World Pharmacology and Therapeutics Forum

Singapore, Singapore
June 07-08, 2021

2rd European Conference on Pharmacovigilance and Drug Safety

Prague, Czech Republic
August 16-17, 2021

34rd World Congress on Pharmacology

London, UK

Innovative Clinical Approach in Biosimilars Conference Speakers

Recommended Sessions

Related Journals

Are you interested in