Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / 10-14 September 2007 1 |1 | Prequalification programme:

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Presentation transcript:

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |1 | Prequalification programme: Priority essential medicines Training Workshop for evaluators from National Medicines Regulatory Authorities in the East African Community: Evaluation of quality and interchangeability of medicinal products. Dar Es Salaam United Republic of Tanzania 10 – 14 September 2007

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |2 | Training Workshop on Evaluation of quality and interchangeability of medicinal products. Innovator versus generic Presenter: Drs. J. Welink Senior pharmacokineticist Medicines Evaluation Board, NL WHO adviser

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |3 | Innovator Innovator dossier QUALITY CLINICAL PRE-CLIN. PHARMACOVIGILANCE

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |4 | Innovator QUALITY

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |5 | Innovator QUALITY Manufacture: active substance specifications starting materials process conditions

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |6 | Innovator QUALITY Characterisation structure: active substance spectroscopic impurities process solvents/reagents control of drug substance (specifications) degradation products

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |7 | Innovator QUALITY Stability: active substance accelerated (i.e. 40°C/75% RH) Iong term storage conditions extreme humidity thermal photolytic oxidative stress basic acidic conditions

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |8 | Innovator Pharmaceutical development: manufacturing process control excipients control critical steps validation manufact. process - conform requirements USP/NF and Pharm. EU - excipients human/animal origin (risk of TSE) control drug product - release specifications - shelf-life specifications QUALITY drug product

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September |9 | Innovator Characterisation structure: justification specifications characterisation impurities appearance potency/degradates identity dose uniformity by weight dissolution tests moisture specifications microbiol. limits test QUALITY drug product

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator Container closure system: package safety compatibility stability QUALITY drug product

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLINICAL

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacology: primary/secondary pharmacodynamics safety pharmacology pharmacodynamic drug interactions QT

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics:

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics: ABSORPTION IV/PO BIOAVAILABILITY DOSE DEPENDENCY

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics: DISTRIBUTION

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics: METABOLISM IN VITRO hepatocytes/microsomes incubation drug recovery

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics: METABOLISM IN VIVO

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics: METABOLISM Interspecies extrapolation ?

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. Pharmacokinetics: EXCRETION INPUT OUTPUT

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator PRE-CLIN. TOXICOLOGY: genotoxicity single/repeat dose carcinogenicity reproductive/ developmental local tolerance ecotox.

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL Pharmacokinetics: ABSORPTION DISTRIBUTION METABOLISM EXCRETION

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL Pharmacokinetics: ABSORPTION BIOAVAILABILITY FOOD EFFECT BIOEQVALENCE TRIAL FORMULATIONS absolute relative + -

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL Pharmacokinetics: DISTRIBUTION Vd PROTEINBINDING ANIMAL DATA TISSUE albumin AAG

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL Pharmacokinetics: METABOLISM IN VITRO hepatocytes/ microsomes human liver microsomal preparations recombinant enzymes (cloned CYP enzymes)

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL Pharmacokinetics: METABOLISM IN VIVO 14 C - interconversion - PK metabolites

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL Pharmacokinetics: EXCRETION

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL PHARMACOKINETICS: elderly gender race paediatrics liver/renal impairment interactions

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator CLINICAL EFFICACY PATIENT STUDIES SAFETY DOSE RESPONSE AEs DRUG RESISTANCE OVERDOSE IMMUNOLOGICAL pharmacovigilance

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Innovator OVERVIEW

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Generic WHAT IS THE DIFFERENCE BETWEEN INNOVATOR AND GENERIC?

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Generic WHAT IS THE RELATION BETWEEN INNOVATOR AND GENERIC? INNOVATOR GENERIC BE

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | Generic GENERIC DOSSIER QUALITY PART: IN LINE INNOVATOR PRE-CLINICAL PART: ONLY REFERENCE CLINICAL PART: PHARMACOKINETICS: bioequivalence studies EFFICACY/SAFETY: only reference

Evaluation of quality and interchangeability of medicinal products - EAC/EC/WHO Training workshop / September | End