Drug Development & Regulation

Phase IV Study

TRFaz IV Çalışma
Also known as:Phase 4 study · Post-marketing study · Post-authorization study

A study conducted after a medicine has received marketing authorization to gather further information on its safety, effectiveness and optimal use, or on its use in populations and settings not studied before approval.

In depth

Post-authorization studies may be interventional trials or observational designs such as cohort, case–control and registry studies, and may be required by the regulator as a condition of authorization, for example as post-authorization safety or efficacy studies. They complement spontaneous reporting within pharmacovigilance.

Post-marketing experience can reveal rare, delayed or interaction-related harms not detected before approval; the withdrawals of rofecoxib (cardiovascular events) and cerivastatin (fatal rhabdomyolysis) are well-known examples.

Clinical pearl

Prescribers and pharmacists contribute directly to post-marketing safety knowledge by reporting suspected adverse reactions to the national pharmacovigilance center (TÜFAM in Turkey).

Example drugs

Rofecoxib Cerivastatin
TRIn Turkish

Faz IV Çalışma

Bir ilacın ruhsat almasından sonra güvenliliği, gerçek yaşamdaki etkililiği ve en uygun kullanımı ya da ruhsat öncesinde incelenmemiş popülasyon ve koşullardaki kullanımı hakkında ek bilgi toplamak amacıyla yürütülen çalışmadır.

Ruhsat sonrası çalışmalar girişimsel klinik araştırmalar ya da kohort, olgu–kontrol ve hasta kaydı (registry) çalışmaları gibi gözlemsel tasarımlar olabilir ve düzenleyici otorite tarafından ruhsatın koşulu olarak, örneğin ruhsat sonrası güvenlilik veya etkililik çalışması şeklinde istenebilir. Farmakovijilans kapsamında spontan bildirimleri tamamlarlar.

Pazarlama sonrası deneyim, onay öncesinde saptanamayan nadir, geç ortaya çıkan ya da etkileşimle ilişkili zararları ortaya koyabilir; rofekoksibin (kardiyovasküler olaylar) ve serivastatinin (ölümcül rabdomiyoliz) piyasadan çekilmesi bilinen örneklerdir.

Hekimler ve eczacılar, şüpheli advers reaksiyonları ulusal farmakovijilans merkezine (Türkiye'de TÜFAM) bildirerek ruhsat sonrası güvenlilik bilgisine doğrudan katkıda bulunur.

Diğer adları:Faz 4 çalışması · Ruhsat sonrası çalışma · Pazarlama sonrası çalışma
Updated 24.09.2026 1 views Educational reference — verify against current sources before clinical use.

Read next

Phase III Clinical TrialFaz III Klinik Araştırma

A large, usually randomized and controlled confirmatory study in patients that establishes the efficacy and safety of a drug at the intended dose and provides the pivotal evidence for marketing authorization.

 PharmacovigilanceFarmakovijilans

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (WHO definition).

 Safety SignalGüvenlilik Sinyali

Information from one or more sources suggesting a new potentially causal association, or a new aspect of a known association, between a medicine and an event, judged sufficient to justify verification.

 Spontaneous ReportingSpontan Bildirim

The unsolicited submission of reports of suspected adverse drug reactions, mainly by healthcare professionals and patients, to a national pharmacovigilance centre or to the marketing authorisation holder.

 Cohort StudyKohort Çalışması

An observational study that follows groups of people defined by their exposure (e.g., to a drug) over time and compares the incidence of outcomes between exposed and unexposed groups.

 Marketing AuthorizationRuhsat

The license granted by a competent regulatory authority that allows a medicinal product to be placed on the market, based on assessment of its quality, safety and efficacy for defined indications and conditions of use.