Regulatory Requirements and Approaches

Bioequivalence regulations have made stricter, yet there is ample scope of improvement in present bioequivalence study designs. Areas where amendments are desired include: general study design, blinding, gender of subject, female subjects, body mass index, and replacement of subjects on withdrawal or, dropouts, genetic phenotyping, endogenous substances, emesis / vomiting and washout period, respectively. Bioavailability and Bioequivalence studies are conducted in healthy human volunteer in study centre. Study centres requires Clinical Pharmacology Unit (CPU) and Bio analytical laboratory. The design and conduct of comparative bioavailability studies are formulated. Investigator(s) should have appropriate expertise, qualifications and competence to undertake a proposed study and is familiar with pharmacokinetic theories underlying bioavailability studies. The design should be based on a reasonable knowledge of the pharmacodynamics and the pharmacokinetics of the active substance in question. BA/BE studies are needed by regulations to guarantee remedial proportionality between a pharmaceutically comparable test item and a reference item. BA/BE studies are finished Early and late clinical trial definitions, Formulations utilized as a part of clinical trial and steadiness studies.

  • WHO Approaches
  • FDA Approach and regulations
  • TGA and risk management approach
  • Food-Effect Bioavailability and Fed Bioequivalence Studies
  • European Guidelines

Related Conference of Regulatory Requirements and Approaches

April 22-23, 2019

20th Asia-Pacific Pharma Congress

Tokyo, Japan
April 25-26, 2019

14th Annual Meet on Euro Ethnopharmacology

Holiday Inn Amsterdam – Arena Towers | Hoogoorddreef 66a, 1101 BE Amsterdam, Netherlands
May 06-07, 2019

11th World Congress on Neuropharmacology

Prague, Czech Republic
May 20-22, 2019

21st Annual European Pharma Congress

Zurich, Switzerland
June 03-04, 2019 | London, UK

6th World Congress and Exhibition on Antibiotics and Antibiotic Resistance

Venue: Park Inn by Radisson Hotel & Conference Centre London Heathrow United Kingdom
June 14-15, 2019 |

13th World Drug Delivery Summit

Montreal, Canada
July 29-30, 2019

7th European Biopharma Congress

Stockholm, Sweden
June 27-28, 2019

4th Pharmaceutical Chemistry Conference

Amsterdam, Netherlands
June 27-28, 2019

18th Annual Congress on Pharmaceutics & Drug Delivery Systems

Amsterdam, Netherlands
June 27-28, 2019

12th World Congress on Future Pharma

Amsterdam, Netherlands
July 15-16, 2019

6th World Congress on Drug Discovery & Toxicology

Abu Dhabi, UAE
July 19-20, 2019

8th International Conference on Clinical Trials

| Atlanta, USA
August 02-03, 2019

9th International Conference on Pharmaceutical GMP, GCP & Regulatory Affairs

| Pharmaceutical Research, Education, Expo & Networking | Chicago, USA
August 19-20, 2019

24th World Congress on Pharmacology

Vienna, Austria
September 11-12, 2019

14th World Congress on Pharmacology and Toxicology

Singapore
September 11-12, 2019

World Congress on Drug Discovery and Drug Design

Singapore
September 18-19, 2019

6th World Congress on Natural Products, Medicinal Plants and Traditional Medicines

| Radisson Narita | Tokyo, Japan
October 10-11, 2019

15th World Congress on Medicinal Chemistry & CADD

Dubrovnik | Croatia
October 14-15, 2019

19th World Congress on Advances in Pharmaceutical Sciences

Courtyard Marriott Seoul Times Square | Seoul, South Korea
October 17-18, 2019

International Conference on Global Analytica

Bangkok , Thailand
October 23-24, 2019 | Amsterdam, Netherland

12th Pharma Congress

Oct 25-26, 2019

11th Annual Biomarkers and Clinical Research Congress

| Copenhagen, Denmark
October 25-26, 2019

14th International Conference on Biopharma and Biotherapeutics

| Copenhagen, Denmark
November 04-05, 2019

Advanced Pharmaceutics and Clinical Research

| Paris, France
September 11-12, 2019

2nd Annual Pharmaceutical Biotechnology Congress

Singapore
November 11-12, 2019

20th Annual Pharma Middle East Congress

Istanbul, Turkey
November 14-15, 2019

2nd World Congress on Bioorganic and Medicinal Chemistry

Cape Town, South Africa
November 18-19, 2019

27th Global Experts Meeting on Neuropharmacology

Rome, Italy
December 02-03, 2019

14th World Congress on Pharmacology and Drug Safety

Nice, France
December 09-10, 2019

20th World Congress on Analytical and Bioanalytical Chemistry

Kuala Lumpur, Malaysia

Regulatory Requirements and Approaches Conference Speakers

Recommended Sessions

Related Journals

Are you interested in