'Bioequivalence studies' presentation slideshows

Planning a BE Study

875 views • 62 slides

708 views • 56 slides

Bioequivalence studies: Regulatory Requirements on Conduct & Documentation of BE.

1.26k views • 47 slides

Bioequivalence studies: Regulatory Requirements on Conduct & Documentation of BE.

474 views • 47 slides

Why are bioavailability / bioequivalence studies necessary?

Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities. Why are bioavailability / bioequivalence studies necessary? An Introduction to Bioequivalence Studies

1.19k views • 38 slides

Regulatory Requirements for Pharmaceutical Generics MFPD Conference Montreal June 21, 2010

Regulatory Requirements for Pharmaceutical Generics MFPD Conference Montreal June 21, 2010. Eric Ormsby Therapeutic Products Directorate. Outline. History of bioequivalence Regulations to support generic drugs Guidance relevant to generic drugs Proposed changes to guidance.

528 views • 33 slides

Prequalification programme: Priority essential medicines

449 views • 28 slides

Regulatory Submission Process

Regulatory Submission Process. Clinical Study Application: Submit an appointment request Fill one of the three templates: BE / BA study Phases I-III Study Phase IV ( Observational) Study. Regulatory Submission Process. Complete the application by submitting all the required Documents :

423 views • 23 slides

Regulatory Submission Process

Regulatory Submission Process. Clinical Study Application: Submit an appointment request Fill one of the three templates: BE / BA study Phases I-III Study Phase IV ( Observational) Study. Regulatory Submission Process. Complete the application by submitting all the required Documents :

838 views • 23 slides

Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO Accra, 5.

Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities. Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO

284 views • 14 slides

MPA requirements on validation of bioanalytical methods

MPA requirements on validation of bioanalytical methods. The analytical method should be validated before analysing of specimens from GLP and GCP studies are done. The validation should be reported as a validation report.

196 views • 4 slides