Bioequivalence Pharmacovigilance HTTP API and External

Data Structure for This Category

Bioequivalence study data primarily originates from clinical trial reports, pharmacokinetic (PK) and pharmacodynamic (PD) data, and adverse event (AE) reports. This data often exists in structured tabular formats, such as CDISC (Clinical Data Interchange Standards Consortium) compliant SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets, or as unstructured text reports. For update frequency, clinical trial data generates continuously during trials. Adverse event reports are submitted in real-time or periodically; for example, the ICH E2B standard requires serious adverse reaction reports within specific timeframes. Fields include subject ID, dosing regimen, plasma concentration, area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax) for pharmacokinetic parameters, and adverse event description, occurrence date, severity, and outcome. Units strictly follow international standards, such as plasma concentration commonly using nanograms/milliliter (ng/mL) and time units in hours (h).

Constraints Imposed by These Characteristics on "HTTP API and External Systems"

The diversity and update frequency of bioequivalence data impose specific requirements on HTTP API design. Structured data, such as PK/PD parameters, requires APIs to support batch uploads and precise field mapping to ensure accurate import of key metrics like AUC and Cmax. Unstructured text reports, such as adverse event descriptions, require APIs to handle request bodies containing large amounts of free text, potentially involving compatibility considerations for text encoding formats. Real-time or periodic updates of adverse event reports mean HTTP APIs need to support high concurrent requests and possess idempotent processing mechanisms to prevent duplicate data entry. Furthermore, because bioequivalence data involves sensitive clinical information, API security, such as TLS encrypted transmission, and strict authentication and authorization mechanisms are essential. The standardization requirement for data units mandates that APIs maintain unit consistency during data transfer, avoiding data anomalies caused by unit conversion errors.

Configuration Settings

Configuration Item	Recommended Value	Rationale
`requestTimeoutSeconds`	`600 seconds`	Bioequivalence report data is large and complex to process, requiring longer API response times.
`maxPayloadSizeMB`	`200 MB`	Transferring request bodies containing large amounts of PK/PD data or detailed adverse event text requires support for larger payloads.
`concurrentConnections`	`Calibrate based on actual measurements`	Adverse event report submission is real-time; determine after stress testing with actual concurrency.
`authHeaderName`	`Authorization`	Industry standard practice for secure authentication, e.g., `Bearer Token`.
`responseBodyEncoding`	`UTF-8`	Ensures correct parsing of multilingual characters in unstructured text data, especially in adverse event descriptions.
`retryAttempts`	`3 times`	Addresses network fluctuations or transient external system failures, improving data transmission reliability.

Three Common Mistakes

Symptom: After an external system calls the HTTP API, some pharmacokinetic parameter fields are empty or have abnormal values. Reason: The data structure returned by the API does not match expectations, or JSON field names have case mismatches during mapping.
Symptom: When sending adverse event reports to an external system, tls: failed to verify certificate errors occasionally occur. Reason: The FastGPT deployment environment is not correctly configured or does not trust the external system's TLS certificate chain.
Symptom: During batch import of bioequivalence data, the API response times out, leading to data import failure. Reason: The amount of data in a single request is too large, exceeding the requestTimeoutSeconds setting, or the external system's processing capacity is insufficient.

How to Verify Configuration

Use Postman or a similar HTTP client to simulate sending a request containing complete structured bioequivalence data. Check if FastGPT correctly parses all key fields like AUC and Cmax.
Send a request containing an unstructured adverse event description. Confirm the API returns a 200 OK status code and the text content is retrievable in the FastGPT knowledge base.
During peak periods or simulated high-concurrency scenarios, continuously send requests. Observe if the concurrentConnections limit takes effect and check external system logs for records of connections being rejected due to excessive numbers.
Inspect network traffic between FastGPT and the external system. Confirm data transmission is encrypted via TLS and no sensitive information is exposed in plain text.

The values provided are common starting points and should be measured against specific samples.

Question material comes from public community discussions. Configuration values are common starting points and should be measured against your own samples. Verified on 2026-09-21.