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145 in total

1. Comparison of different methods to evaluate population dose-response and relative potency: importance of interoccasion variability.

Authors: R L Lalonde; D Ouellet; E K Kimanani; D Potvin; L M Vaughan; M R Hill
Journal: J Pharmacokinet Biopharm Date: 1999-02

Review 2. Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.

Authors: L J Lesko; M Rowland; C C Peck; T F Blaschke
Journal: Pharm Res Date: 2000-11 Impact factor: 4.200

3. Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.

Authors: R L Williams; W Adams; M L Chen; D Hare; A Hussain; L Lesko; R Patnaik; V Shah
Journal: Eur J Drug Metab Pharmacokinet Date: 2000 Jan-Mar Impact factor: 2.441

Review 4. Bioavailability and bioequivalence: an FDA regulatory overview.

Authors: M L Chen; V Shah; R Patnaik; W Adams; A Hussain; D Conner; M Mehta; H Malinowski; J Lazor; S M Huang; D Hare; L Lesko; D Sporn; R Williams
Journal: Pharm Res Date: 2001-12 Impact factor: 4.200

Review 5. Concentration-controlled or effect-controlled trials: useful alternatives to conventional dose-controlled trials?

Authors: A Grahnén; M O Karlsson
Journal: Clin Pharmacokinet Date: 2001 Impact factor: 6.447

Learning versus confirming in clinical drug development.

1. Comparison of different methods to evaluate population dose-response and relative potency: importance of interoccasion variability.

Review 2. Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.

3. Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.

Review 4. Bioavailability and bioequivalence: an FDA regulatory overview.

Review 5. Concentration-controlled or effect-controlled trials: useful alternatives to conventional dose-controlled trials?

Review 6. Economic evaluations during early (phase II) drug development: a role for clinical trial simulations?

7. Population pharmacokinetic-pharmacodynamic modelling of angiotensin receptor blockade in healthy volunteers.

Review 8. Pharmacokinetic-pharmacodynamic guided trial design in oncology.

Review 9. Role of modelling and simulation: a European regulatory perspective.

10. Rapid sample size calculations for a defined likelihood ratio test-based power in mixed-effects models.